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gastric balloon

Spatz Balloon FDA Post-approval Study Eligibility

01/12/2021 by DrCurry Leave a Comment

spatz 3 adjustable gastric balloon

The Spatz gastric balloon has recently been approved by the FDA in the US, and over 100,000 have been implanted outside the US over the last decade.  When the FDA approves a medical device, the manufacturer of the device must do a “Post Approval Study” (commonly abbreviated as “PAS”) on their device and submit data on actual patients in whom the device was implanted.

JourneyLite has participated in post approval studies on all gastric balloon systems that have come to market in the US, and we are proud to have been selected to participate in the Spatz PAS.

There are always specific criteria for patient inclusion and exclusion, and in order to be considered for participation in the Spatz PAS a patient must meet the following guidelines:

Inclusion Criteria (you must meet all of these conditions to be considered for the study):

  1. Age 22-65
  2. BMI 35-40, or BMI 30-34.9 with one or more major obesity-related conditions (diabetes, hypertension, sleep apnea, etc)
  3. Willing to comply with substantial lifelong dietary restrictions required by the procedure
  4. History of obesity (BMI 30+) for at least 2 years
  5. History of failure with non-surgical weight loss methods
  6. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
  7. Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow-up visits
  8. Ability to give informed consent
  9. Women of childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.  Acceptable methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence.

Exclusion Criteria (if you have any of these things you cannot be in the study):

  1. Prior surgery involving the esophagus, stomach, and duodenum or hiatal hernia surgery
  2. Prior open or laparoscopic bariatric surgery
  3. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammation such as Crohn’s disease
  4. A gastric mass
  5. A hiatal hernia >2cm or severe or intractable gastro-esophageal reflux symptoms
  6. Acid reflux symptoms to any degree that require more than one medication for symptom control
  7. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope
  8. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
  9. Severe coagulopathy
  10. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months
  11. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
  12. Chronic abdominal pain
  13. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
  14. Hepatic insufficiency or cirrhosis
  15. Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months
  16. Alcoholism or drug addiction
  17. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up
  18. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants
  19. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
  20. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system
  21. Patients who have BOTH:
    a. A previous history of a serotonin syndrome
    AND
    b. currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)]
  22. Patients who are pregnant or breast-feeding
  23. Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs
  24. Subjects who have tested positive for H. Pylori, and who have not yet been treated

Patients who participate in this trial will need to have some pre-procedure testing done.  Click here for more info.

If you are interested in the Spatz gastric balloon PAS and you meet the above criteria, the next step in the process would be to schedule a consultation with one of our physicians to discuss the procedure and the study in more detail.

Appointment Request -Balloon

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Filed Under: Uncategorized Tagged With: gastric balloon, spatz

Spatz Adjustable Gastric Balloon

04/11/2021 by DrCurry Leave a Comment

spatz 3 adjustable gastric balloon

The Spatz 3 adjustable gastric balloon was approved by the FDA in the United States in 2021.  It is indicated for patients with a body mass index (BMI) of 35-40, or a BMI of 30-35 with an obesity related medical issue.  Spatz 3 has been available outside the US for some time, and over 100,000 have been implanted.

 

What makes the Spatz unique is that it is the only adjustable balloon system.  This is important for several reasons:

  • One of the most common complications for traditional saline-filled balloons is balloon interolerance.  This means that a small percentage of patients will not tolerate their balloon and will have ongoing issues with vomiting and discomfort.  In the past, if these issues persisted beyond a week or so then the balloon was typically removed early.  With the Spatz however, some saline can be removed from the balloon which will usually cause these issues to resolve without balloon removal.  This does require a repeat endoscopy, however.
  • Another issue with saline balloons in the past is that some patients will only lose weight for the first few months.  These patients will either have a weight loss plateau or even weight gain.  If this occurs with a Spatz, some additional saline can be added to the balloon which will usually lead to additional weight loss.  This also requires a repeat endoscopy.

An additional benefit of the Spatz is that it can be left in the stomach for 8 months, as opposed to a maximum of 6 months for other saline gastric balloons that have been approved in the US.

These advantages have resulted in significantly better weight loss and long-term success for the Spatz balloon in their FDA trial than for any other gastric balloon, whether saline or gas-filled.

Spatz balloon results

As can be seen in the above table comparing all gastric balloons with which we have experience, the Spatz has not only the best weight loss, but also the highest success rate.

Currently, only patients who are able to participate in the Spatz FDA Post-approval Study can have one of these balloons implanted.  Click here if you’re interested to find out if you may be eligible!

How the Spatz Adjustable Gastric Balloon Teaches You to Eat Less!

Filed Under: Anouncements, Education Tagged With: gastric balloon, spatz

Gastric Balloon Pre & Post Procedure Instructions

Please review the instructions below before and after your gastric balloon!

Pre/Post Procedure+Days 0-7

Orbera and Spatz Intragastric Balloon

Pre-op and Post-op Instructions

JourneyLite Physicians

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Gastric Balloon Pre-Post Instructions 265.24 KB 2495 downloads

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Gastric Balloon Pre_Post Instructions-Saline

Diet: Days 1-7

Gastric Balloon Week 1 Diet

Days 1 – clear liquids only

  • 100% fruit juice (apple, grape, cranberry)
  • Clear broth (chicken, beef, and vegetarian)
  • Sugar free popsicles
  • Sugar free gelatin
  • Water and/or ice chips
  • Crystal Light or Sugar Free Kool-Aid
  • Decaf Teas and Coffee
  • JourneyLite Supplements: fruit drinks, gelatin, protein bouillon, and hot beverages available at LoseWeightCincy.com and all office locations

 

Avoid the following items day 1

  • Carbonated beverages
  • Sugary drinks (sweet teas)
  • Citrus juices (orange, grapefruit, pineapple) and tomato juices
  • Juice drinks (Hawaiian punch)

 

Days 2-7 – full liquid/puree

  • Protein Shakes (Premier shakes, Atkins, Low Carb Slim Fast
  • Yogurt (carbmaster, Fit and Lite Greek High Protein)
  • Milk (skim, 1%, skim milk, almond milk, soy milk) (all unsweetened)
  • V-8 juice, tomato juice
  • Scrambled eggs
  • Sugar free pudding
  • Cream soup (strained):  cream of chicken, cream of mushroom, cream of broccoli
  • JourneyLite Supplements: protein shakes and pudding, oatmeal, mash potatoes, scrambled eggs, tomato soup

 

Avoid the following items days 2-7

  • Foods with chunks or large pieces
  • Sugary desserts (ice cream, regular pudding, cream pies)
  • Carbonated beverages

 

After seven days, you can transition to semi-solid foods. You gradually will transition to solid foods. The length of time for this transition depends on how your body is adjusting to the process. Don’t rush and be sure your body is comfortable before you move into the next phase of eating!

 

Some Helpful Tips:

  • Plan 3 small meals and 2 small snacks every day.
  • Watch your posture during meals and while drinking fluids.  Sit tall and do not slouch.  This will help with your balloon position properly and increase your tolerance for solids.
  • Stop eating when you feel full.  One additional bite may be too 
  • Do not drink liquids for 30 minutes before your meal and wait 30 minutes after to drink.
  • No solid food starting 3 hours prior to bedtime.
  • Use your anti-nausea medications as prescribed by the physician.
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Gastric Balloon Days 1-7

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Gastric Balloon Soft Diet

Diet: Days 8-14

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Gastric Balloon Soft Diet

Diet: Days 15+

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Gastric Balloon Regular Diet 126.00 KB 1369 downloads

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Gastric Balloon Regular Diet

Balloon Removal

Removing Your Intragastric Balloon

IMPORTANT: All Spatz gastric balloons must be removed after 8 months.  All Orbera gastric balloons must be removed after 6 months.  Please contact our scheduling team immediately if your balloon has been in for 3 months or more and you do not have a removal date scheduled!

For further important instructions on how to prepare for your gastric balloon removal, click here.


New Year 2019 Special: Obalon Swallowable Gastric Balloon Only $6000!

22/12/2018 by DrCurry Leave a Comment

Offer Expired!

Let’s face it, not too many people go into the new year withOUT a resolution to lose weight and improve their health. If you want to give yourself a fighting chance to lose 30-50 pounds* you might want to think about JourneyLite Physicians and a gastric balloon such Obalon, ReShape, or Orbera.

Obalon Capsule and Inflated Balloon

Background

Gastric balloons come in 2 difference classes: saline-filled (ReShape & Orbera) and gas-filled (Obalon Swallowable Gastric Balloon). The saline balloons require a procedure with sedation and endoscopy to place them, while with the Obalon the patient simply swallows a capsule in the office, which then gets inflated in their stomach.

As far as side effects go, nausea and vomiting can be a major issue with the saline balloons such as Orbera and ReShape. Patients will usually need to take 3-5 days off work afterwards until their stomach has accomodate their new balloon. Some patients just can’t tolerate a saline balloon and it has to be removed early.

Gas-filled balloons such as the Obalon Swallowable Gastric Balloon however, have a much lower nausea/vomiting rate, in fact most patients have no vomiting at all after placement. There are a couple of reasons for this: 1) a gas-filled balloon is lighter than the fluid in the stomach and will float on top, and 2) the Obalon system is a gradual treatment where the patient receives one small balloon at a time for a total of 3 over an 8-12 week period.

All gastric balloons, whether saline or gas-filled, need to be removed after 6 months, which does require a brief endoscopic procedure with sedation. However there are typically no side effects from removal and patients can return to work the next day.

Goals

Weight loss goals are the same for all balloons, hoping for 30-50 pounds over the 6 months that the balloon is in. Once removed, the patient must be committed and work hard to keep the weight off. Registered dietitians on the team will meet with patients monthly to tweak diet plans and encourage exercise. In some cases the use of a long-term appetite suppressant such as Qsymia, Belviq, or Contrave can be useful.

New Year Savings!

Dr. Trace Curry and his team at JourneyLite Physicians are some of the most experienced in the US for gastric balloons. With any procedure, experience leads to better results and a lower complication rate. To help you with your New Year’s weight loss resolution, we are offering the Obalon system for a limited time for just $6000.00! This includes three balloon swallows, endoscopic removal at 6 months, and a 6 month registered dietitian program.

Call now or click below to request a consultation with Dr. Trace Curry! For your convenience we have offices in Cincinnati, Northern Kentucky, Columbus, and Dayton. Virtual visits are also available for out-of-town patients through our new smartphone app, “HealthTrac“.

Request Appointment!

Cincinnati: (513) 559-1222 Northern Ky: (859) 331-1035

Columbus: (614) 526-4463 Dayton: (937) 280-LOSE

*Individual results may vary.

Filed Under: Anouncements Tagged With: gastric balloon, obalon

Get up to $1500 of off the new Obalon Swallowable Gastric Balloon! – offer expired 8/31

23/08/2018 by DrCurry 4 Comments

obalon only gas filled gastric balloon

The Obalon system is the only FDA-approved, swallowable, gas-filled gastric balloon in the US, and we have been seeing some fantastic results with it.  Dr. Trace Curry does these procedures right in the office.  You can literally come in on your lunch break, have the procedure done, and go right back to work!  A unique design involves a swallowable capsule that is slighly larger than a big multivitamin with a long tiny cather attached.  The patient simply swallows the capsule, the doctor confirms the location with a simple brief Xray, and then the balloon is inflated with a gas mixture.  The process is repeat for a total of 3 balloons over several weeks.

The advantage of the gas-filled Obalon system is twofold:

  1. unlike saline-filled balloons, gas-filled balloons float on top of the fluid in the stomach, so they are less likely to obstruct the outlet and cause vomiting
  2. the Obalon system is a gradual treatment, as opposed to saline balloons where the entire volume is done all at once

The end result is much fewer side effects, in fact we have seen no vomiting issues in any of our Obalon patients.  Mostly patients experience some nausea and cramping for a day or two which is treated with medications.

Paired together with our HealthTrac app and our team of registered dietitians, Obalon gives you the potential to lose in many cases up to 50 lbs over the six month interval that the balloons remain in.

After 6 months, the balloons must be removed with a simple endoscopic procedure.

Obalon up to $1500 offThe Obalon system is $7500 which includes 3 balloon swallows, endoscopic removal, 6 months of dietitian appointments, and HealthTrac app access.  For a limited time you can get up to $1500 off of your procedure!

Losing up to 30 to 50 lbs can be a life-changing experience, call to schedule a consultation with Dr. Trace Curry, a leading gastric balloon expert, or click here to request an appointment.  Virtual appointments are available for out-of-town patients.

NOTE: This procedure is not covered by insurance, although it may be a tax-deductible medical expense and it typically can be payed for with Health Savings Account funds as it is an FDA-approved treatment for obesity.

Filed Under: Anouncements, Education Tagged With: gastric balloon, obalon

Obalon Pre-Procedure Meds

16/05/2018 by DrCurry 2 Comments

obalon pillThe Obalon swallowable gastric balloon is unique in that treatment is gradual, and the balloons are filled with nitrogen gas which makes them float on top of the gastric contents.  These are the primary reasons that Obalon patients tend to have much less nausea and vomiting than patients receiving traditional saline-filled balloons.  Although symptoms are usually minimal, we highly recommend a pre-procedure medication regimen that will reduce symptoms even further.

It is recommended to start this regimen THE DAY BEFORE each scheduled balloon swallow:

  • Zofran (generic ondansetron) – 4mg tablets
    • Take one tablet every 6 hours.
    • Start the morning before each balloon swallow and continue until your appointment.
    • Continue for 24 hours after then use as needed.
  • Levbid (generic hyoscamine) – .375mg tablets:
    • Take one tablet every 12 hours by mouth with a sip of water.
    • Start the morning before each balloon swallow and continue until your appointment.
    • Continue for 24 hours after then use as needed.

These medications can be ePrescribed for you, so if you have not yet given us your pharmacy information please call us with the pharmacy name and full address (with zip code).

It is required to have liquids only on the day of the balloon swallow, with minimal intake for two hours immediately prior to the appointment to ensure that the stomach is fairly empty.

After the swallow you must do clear liquids only for the next 24 hours, pureed food for 24 hours after that, then you can transition to solids on the 3rd day.

 

Filed Under: Education Tagged With: gastric balloon, obalon

Obalon Placebo Swallow

27/04/2018 by DrCurry Leave a Comment

The Obalon “Swallowable” Gastric Balloon is a unique new treatment for obesity.  Since the capsule itself is slightly bigger than a large multivitamin capsule, we need to make sure the patient can swallow it adequately beforehand.   We do this with what is called an “Obalon placebo swallow.”

Obalon supplies us with dissolvable capsules that are the exact same size as the balloon capsule itself, so the patient can swallow this in the office so that we can observe the patient.  In the rare event that it doesn’t go down, it will dissolve within a few minutes and pass into the stomach.

We do two back-to-back placebo swallows, just to make sure and give the patient confidence that they won’t have any trouble on the day of their Obalon swallow!  No special preparation is required, but it is best to not eat any solid food for a couple hours prior to your appointment.

Dr. from New Jersey demonstrates how easy this is in this YouTube video:

Filed Under: Education Tagged With: gastric balloon, obalon

Get $500 off-up to $1000 in rebates!

23/04/2018 by DrCurry 2 Comments

obalon pillFor a limited time you can get up to $1000 total off your procedure!

Dr. Trace Curry at JourneyLite Physicians was just approved to do the new Obalon “swallowable” gastric balloon procedure.  We will be offering this unique new swallowable balloon technology at our main Cincinnati location, but will be seeing patients for consultations in our Cincinnati, Columbus, Dayton, and Northern Kentucky offices.  If you are an out of town patient and are interested in an Obalon gastric balloon consult, virtual consultations are also available.

For a limited time you can get $500 off of your Obalon procedure from JourneyLite, then up to $500 in additional rebates from Obalon!  Terms & restrictions aply, click here for more info.

The Obalon gastric balloon is new technology that allows patients to have a balloon placed by swallowing a small capsule in the office, rather than requiring anesthesia and endoscopy.  The procedure takes only 10 minutes, and patients can be on their feet and back to work almost immediately!  In contrast to saline filled balloons, Obalons are filled with inert nitrogen gas, and are smaller than traditional saline balloons such as ReShape and Orbera.  Patients return every 4 weeks and swallow another capsule for a total of 3 balloons and 750cc.  This difference in technique results in greater tolerance and less down-time than saline balloons.

Dr. Trace Curry and JourneyLite Physicians are the most experienced gastric balloon doctors in the mid-west, and we are excited to offer this new minimally invasive, non-surgical treatment to our patients!

Call now or click below to schedule your consultation!

Click here to request a consultation with Dr. Curry for the Obalon gastric balloon!

Filed Under: Anouncements Tagged With: gastric balloon, obalon

Obalon “Swallowable” Gastric Balloon in Cincinnati, Ohio

17/04/2018 by DrCurry 2 Comments

In Cincinnati, Ohio our physicians at JourneyLite have done many ReShape and Orbera insertions over the years.  Gastric balloons have been a significant breakthrough in the field of non-surgical weight loss, and now a new device, the Obalon “swallowable” gastric balloon is out.

Overall, advantages of gastric balloons include:

  • lower risk than surgery
  • lower cost than surgery
  • faster recovery than surgery
  • does not permanently alter the patient’s anatomy
  • can be a great kickstart for a patient who is not a candidate for surgery to make a lifestyle change

Up until now, in the US at least, a gastric balloon has required two procedures:  one endoscopy (with anesthesia) to insert the balloon, and then one endoscopy (also with anesthesia) to remove it 6 months later.  The Obalon gastric balloon changes this equation for the better, as it can easily be placed in the office with no anesthesia and no downtime.

Both ReShape and Orbera gastric balloons have more similarities than differences.  Both of them require two endoscopies, both of them are filled with saline, and both of them have a reasonably high rate (8%-16%) of intolerance, which requires early removal of the device.  See Table 1 below for a list of similarities and differences between these devices.

Obalon is a definite game-changer in the gastric balloon world.  Obalon patients receive a total of 3 smaller balloons over a total of 8 weeks.  Each balloon insertion is a simple process:  the patient comes into the office, stands in front of an xray machine, and swallows a capsule with a tiny catheter attached to it.  The physician uses xray to confirm that the capsule is in the stomach, and then it is inflated with a special cannister of gas up to 250cc.  The patient comes back then every 4 weeks until all 3 balloons have been placed.

Obalon Uninflated & Inflated

obalon gastric balloon
This technique has some major advantages over traditional gastric balloons.  Most importantly, increasing the total balloon volume gradually over time results in much better tolerance than inserting an Orbera or ReShape and immediately inflating it up to 900cc’s.  This results in much less nausea and vomiting upon each balloon placement, allowing most patients to return to work the next day.

Their initial trial, SMART, showed excellent safety profile with no balloon leaks or early removal.  Weight loss was roughly double that of the control group.

The development of less-invasive treatments such as Obalon will hopefully allow physicians to attack the disease of obesity much earlier, avoiding major disease like type 2 diabetes and sleep apnea.

Click here to schedule an Obalon “swallowable” gastric balloon consultation!

 

[Read more…] about Obalon “Swallowable” Gastric Balloon in Cincinnati, Ohio

Filed Under: Anouncements, Education Tagged With: gastric balloon, obalon

Obalon Swallowable Gastric Balloon

Due to manufacturer supply issues the Obalon balloon is not currently commercially available.

obalon pill
obalon gastric balloon

Obalon is the first FDA-approved, swallowable, non-surgical gastric balloon in the United States.   This unique gastric balloon comes in the form of a “pill” that is attached to a small catheter.  It can be placed in your physician’s office, without any anesthesia, and placement can be confirmed with an Xray machine.  Once proper placement is confirmed, the balloon is inflated with gas to 250cc.  Unlike the other FDA-approved gastric balloons in the United States, no anesthetic or downtime is required for placement.

One balloon is placed initially, followed by 2 more insertions (every 4 weeks) for a total of 3 balloons and 750cc.  Obalon differs from Orbera and ReShape in several ways:

  • no anesthesia is required for insertion of the Obalon balloons
  • no downtime is required after insertion
  • the sequential placement of balloons results in much better patient tolerance (i.e. less nausea & vomiting)
  • fewer Obalons need to be removed early due to balloon intolerance
  • the Obalon balloon is filled with gas, not saline

Similarites include:

  • similar total balloon volume (in between Orbera [600cc] and ReShape [750-900cc]
  • similar physiologic function of balloon(s), occupying space in the stomach to reduce hunger and help the patient get full on smaller portions
  • similar requirements for success-patient must make meaningful changes in diet/exercise habits and be compliant with all follow-up visits
  • similar in-stomach balloon duration of 6 months
  • similar balloon removal process requiring sedatation and endoscopy

Results submitted to the FDA from Obalon’s SMART trial showed an excellent safety profile with no early balloon removals or balloon deflations and weight loss that was around double that of the placebo group.  As with any gastric balloon system, the patient must make a serious commitment to healthy eating, exercise, and attending all post-procedure nutrition visits to maximize success.

Currently, the Obalon Therapeutics company is undergoing some restructuring, and we are not able to obtain these balloons.  This may change at some point in the future, so check back!

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