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Spatz Adjustable Balloon for Obesity (SABO) (SABO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812160
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Spatz FGIA, Inc

Brief Summary:
The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.

Condition or disease Intervention/treatment Phase
Obesity Device: Spatz3 Adjustable Balloon Not Applicable

Detailed Description:
Device Name: Spatz3 Adjustable Balloon System® (Spatz3) Clinical Phase: Pivotal Trial Design: Multicenter open-label randomized controlled trial Trial Participants: Adults, ages 22-65, with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight control program Control group: Supervised diet and exercise Planned sample size: 282 subjects randomized 2:1 to device/control Follow-up duration: 8 months for control and 14 months for treatment Primary endpoints: Percent change in total body weight (%TBL) at 32 weeks AND Clinical response, where a responder is defined as a subject with at least a 5% loss in total body weight at 32 weeks Secondary endpoints: Maintenance of 40% of the weight loss with the balloon six months after the balloon is removed Clinical response, where a responder is defined as a subject with at least a 25% loss in excess body weight at 32 weeks

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : January 2019

Arm Intervention/treatment
Active Comparator: Spatz3 Adjustable Balloon
Spatz3 Adjustable Balloon with Dietary and exercise counselling
Device: Spatz3 Adjustable Balloon
An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed

No Intervention: Control
Dietary and Exercise counselling



Primary Outcome Measures :
  1. Percent change in total body weight (%TBL) . [ Time Frame: 8 months + 6 month follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 22 - 65
  2. BMI ≥ 30 and <40
  3. Willingness to comply with the 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, 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 birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence. The method of birth control must be documented and verified at follow-up. Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject's obstetrician.

Exclusion Criteria:

  1. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
  2. Prior open or laparoscopic bariatric surgery.
  3. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
  4. 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.
  5. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
  6. A gastric mass.
  7. A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
  8. Acid reflux symptoms to any degree that require more than one medication for symptom control.
  9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
  10. Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
  11. Severe coagulopathy.
  12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
  13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
  14. Chronic abdominal pain
  15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
  16. Hepatic insufficiency or cirrhosis
  17. 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.
  18. Alcoholism or drug addiction.
  19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  20. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
  21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
  22. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
  23. Patients who have ever developed a serotonin syndrome and are 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)] should not undergo placement of the device.
  24. Patients who are pregnant or breast-feeding.
  25. 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
  26. Subjects who have tested positive for H. Pylori.
  27. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
  28. Subjects who are taking corticosteroids, immunosuppressants, and narcotics
  29. Subjects who are taking diet pills
  30. Use of an intragastric device prior to this study due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach.
  31. Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings.
  32. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  33. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
  34. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
  35. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator because of an increased risk profile.
  36. Specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or Prader Willi syndrome
  37. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
  38. Known history of endocrine disorders affecting weight

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812160


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Surgical Specialists of Louisiana
Metairie, Louisiana, United States, 70001
United States, Maryland
Endoscopic MicroSurgery Associates
Towson, Maryland, United States, 21204
United States, Massachusetts
Brigham and Womans Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
NY Manhattan VA Hospital
New York, New York, United States, 10010
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Spatz FGIA, Inc
Investigators
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Principal Investigator: Barham AbuDayyeh, MD Mayo Clinic
Principal Investigator: Christopher C Thompson, MD Brigham and Women's Hospital
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Responsible Party: Spatz FGIA, Inc
ClinicalTrials.gov Identifier: NCT02812160    
Other Study ID Numbers: Spatz-160061
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Spatz FGIA, Inc:
weight loss
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight