Loading clinical trials...

Spatz Adjustable Balloon for Obesity (SABO) | Clinical Trials | Clareo Health

COMPLETEDNA

Spatz Adjustable Balloon for Obesity (SABO)

A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone

NCT02812160•Spatz FGIA, Inc

View on ClinicalTrials.gov

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.

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 study treatment duration: 32 weeks Primary endpoint: Percent change in total body weight (%TBL) at 32 weeks

Eligibility

Age

22 - 65 years

Sex

ALL

Healthy Volunteers

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
+28 more criteria

Locations (7)

University of Chicago

Chicago, Illinois, United States

Surgical Specialists of Louisiana

Metairie, Louisiana, United States

Endoscopic MicroSurgery Associates

Towson, Maryland, United States

Brigham and Womans Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

NY Manhattan VA Hospital

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

September 12, 2016

Primary Completion Date

October 1, 2018

Completion Date

January 1, 2019

Last Updated

May 28, 2021

Enrollment

288

ACTUAL participants

Conditions

Obesity

Interventions

Spatz3 Adjustable Balloon

DEVICE

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

View study

RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Spatz Adjustable Balloon for Obesity (SABO)

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial

Protein Supplementation Intervention on Body Weight

Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss