• Skip to primary navigation
  • Skip to main content

JourneyLite Physicians-Weight Loss, Plastics, and Spine Experts!

Your team for all your weight loss, body contouring, and spine surgery needs! Gastric sleeve, gastric bypass, gastric balloon, appetite suppressants and more!

  • Home
    • JourneyLite Physicians & JourneyLite Surgery Center
    • Our Team
    • Patient Testimonials
    • Physician Resources
    • Refer a Patient
    • Login/Create Account
  • Maps and Contacts
  • Surgical Options
    • Gastric Sleeve (VSG)
    • Lap Band
    • Gastric Bypass
    • SIPS Procedure (Loop Duodenal Switch/SADI)
    • Gastric Band Revision
    • Gastric Sleeve Revision
    • Pricing & Financing
  • Incisionless Options
    • Orbera Gastric Balloon
    • Spatz Adjustable Gastric Balloon
    • Pricing & Financing
  • Medications
    • Adipex, Contrave & Qsymia
    • Wegovy-A New Injectable Weight Loss Drug
    • Plenity-A New, Non-Stimulant Weight Loss Treatment
    • Combination Therapy
    • Pricing
  • Procedure Education
    • Surgical Pre-op Navigator
    • Surgical Post-op Navigator
    • Surgical Post-Op Diet Phases
    • Gastric Balloon Pre & Post Procedure Instructions
    • Gastric Balloon Removal Instructions
  • eStore
  •  

spatz

Testing Required for Spatz Balloon FDA Study

Please take this list with you when you go to have labs drawn for the implantation of the Spatz Balloon and participation in the FDA post-approval study.  Show this list to the technician and make sure the following labs have been drawn.

 

Labs and tests that are required: 

  • CBC: Hgb, Hct, WBC, Platelets
  • Chemistry panel: sodium, potassium, BUN, creatinine, glucose, SGOT(AST), SGPT(ALT), alkaline phosphatase, total cholesterol 
  • TSH 
  • H.Pylori Antibody
  • Hemoglobin A1C (if diabetic)
  • Urine pregnancy test (for women of childbearing age)

___________________________________________________

These additional tests may be required but will typically be done at a hospital outpatient testing department and not at a freestanding lab:

  • EKG (above the age of 40)
  • Chest X-Ray (above the age of 60)

Download the list as a PDF to for printing:

Icon

Testing Required for Spatz Balloon FDA Study

1 file(s) 109.79 KB
Download

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

Request an appointment here!

Step 1 of 4 - Contact Information

25%
  • MM slash DD slash YYYY
  • Please select the program(s) in which you are interested!
  • (for example for 5' 2", enter 5)
  • (for example for 5' 2", enter 2)
  • Please click here to watch the online infosession before requesting an appointment!
  • MM slash DD slash YYYY
  • Terms Of Service

    Submitting this form does not constitute a doctor-patient relationship with Center for Metabolic & Bariatric Surgery, LLC/dba JourneyLite Physicians. Information submitted will not be shared with any third parties except for direct affiliates of Center for Metabolic & Bariatric Surgery, LLC.

  • This field is for validation purposes and should be left unchanged.

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

Icon

Gastric Balloon Pre-Post Instructions 265.24 KB 2495 downloads

Gastric Balloon Pre_Post Instructions-Saline ...
Download
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.
Icon

Gastric Balloon Days 1-7

1 file(s) 74.51 KB
Download
Gastric Balloon Soft Diet

Diet: Days 8-14

Icon

Gastric Balloon Soft Diet

1 file(s) 91.41 KB
Download
Gastric Balloon Soft Diet

Diet: Days 15+

Icon

Gastric Balloon Regular Diet 126.00 KB 1369 downloads

Gastric Balloon Regular Diet ...
Download
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.


Copyright © 2023 · Trace Curry MD · Log in