Trials / Completed
CompletedNCT02235870
Obalon Balloon System Pivotal IDE (SMART) Trial
The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 711 (actual)
- Sponsor
- Obalon Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Obalon Intragastric Balloons | Intragastric Balloon System to aid in portion control. |
| DEVICE | Sham Device | Sham Intragastric Balloon |
| BEHAVIORAL | Nutrition and Lifestyle Program | Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2015-11-01
- Completion
- 2016-05-01
- First posted
- 2014-09-10
- Last updated
- 2018-03-08
- Results posted
- 2018-03-08
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02235870. Inclusion in this directory is not an endorsement.