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Obalon Balloon System Pivotal IDE (SMART) Trial | Clinical Trials | Clareo Health

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Obalon Balloon System Pivotal IDE (SMART) Trial

The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial

NCT02235870•Obalon Therapeutics, Inc.

Summary

This pivotal trial of the Obalon Balloon System is intended to generate safety and effectiveness data required to support a future marketing application. The trial has been designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition and lifestyle behavior modification program. Weight loss will be evaluated after the 6-month course to determine if a specific predefined superiority margin can be achieved in the device group compared to a sham-control group.

Eligibility

Age

22 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female between the ages of 22-64 years
•2. Current BMI of 30.0 - 40 kg/m2
•3. Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet
•4. Willing to attend all protocol-specified follow-up visits plus any additional follow-up visits as required throughout the entire study period
•5. Willing to avoid non-commercial air travel and scuba diving during the entire study period
•6. Willing to avoid medications or other substances known to effect weight changes during the study
•7. Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications known to be gastric irritants during the study
•8. Willing to use contraception and avoid pregnancy during the study if the subject is female with child bearing potential
•9. Willing to provide written informed consent

Exclusion Criteria

•1. Significant weight loss in the past 12 months
•2. Use of medications or other substances known to induce weight gain or weight loss
•3. Participation in any clinical study at the start of this trial or in the last year
•4. Known history of endocrine disorders affecting weight
•5. Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV
•6. Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders
•7. Intent to undergo gastric surgery or gastric banding during the study period or within the 6 month period after completion of this study
•8. Prior use of any weight loss medical device
•9. Known history of structural or functional disorders of the esophagus
•10. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
+21 more criteria

Locations (15)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

Southern California Research Center

Coronado, California, United States

Bariatric Institute of Greater Chicago

Hinsdale, Illinois, United States

Endoscopic Microsurgery Associates

Towson, Maryland, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University Hospital in St. Louis

St Louis, Missouri, United States

Stony Brook Medicine

Stony Brook, New York, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Chattanooga Bariatrics

Chattanooga, Tennessee, United States

Key Dates

Start Date

February 1, 2015

Primary Completion Date

November 1, 2015

Completion Date

May 1, 2016

Last Updated

March 8, 2018

Enrollment

711

ACTUAL participants

Conditions

Obesity

Interventions

Obalon Intragastric Balloons

DEVICE

Sham Device

DEVICE

Nutrition and Lifestyle Program

BEHAVIORAL

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

NCT07472881

MenopausePerimenopause+2 more

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RECRUITING

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

NCT01143454

Metabolic DiseaseObesity+4 more

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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: March 8, 2018Data 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

Obalon Balloon System Pivotal IDE (SMART) Trial

Inclusion Criteria

Exclusion Criteria

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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