Obalon Balloon System Pivotal IDE (SMART) Trial
Public ClinicalTrials.gov record NCT02235870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02235870
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 711 participants
Conditions and interventions
Conditions
Interventions
- Obalon Intragastric Balloons Device
- Sham Device Device
- Nutrition and Lifestyle Program Behavioral
Device · Behavioral
Eligibility (public fields only)
- Age range
- 22 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2015 (Type not available)
- Primary completion
- Nov 2015 (Actual)
- Completion
- May 2016 (Actual)
- Last update posted
- Mar 8, 2018
2015 – 2016
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | — | — |
| Anaheim Clinical Trials | Anaheim | California | — | — |
| Southern California Research Center | Coronado | California | — | — |
| Bariatric Institute of Greater Chicago | Hinsdale | Illinois | — | — |
| Endoscopic Microsurgery Associates | Towson | Maryland | — | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | — | — |
| Washington University Hospital in St. Louis | St Louis | Missouri | — | — |
| Stony Brook Medicine | Stony Brook | New York | — | — |
| West Penn Hospital | Pittsburgh | Pennsylvania | — | — |
| Chattanooga Bariatrics | Chattanooga | Tennessee | — | — |
| Midsouth Bariatrics | Memphis | Tennessee | — | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | — | — |
| Houston Methodist Research Institute | Houston | Texas | — | — |
| University of Utah Hospital | Salt Lake City | Utah | — | — |
| Virginia Mason Medical Center | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02235870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 8, 2018 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02235870 live on ClinicalTrials.gov.