CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 711 enrolled
Drug / intervention
Obalon Intragastric Balloons +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02235870
NCT02235870N/ACompleted
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The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial

Obalon Therapeutics, Inc.·interventional·Posted Sep 10, 2014·Updated Mar 8, 2018

In Brief

A clinical study evaluating Obalon Intragastric Balloons, Sham Device, and 1 other intervention for Obesity. Completed, enrolled 711 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 10, 2014
Enrollment StartFeb 1, 2015
Primary CompletionNov 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.8 years ago

Interventions

Obalon Intragastric Balloonsdevice

Intragastric Balloon System to aid in portion control.

Sham Devicedevice

Sham Intragastric Balloon

Nutrition and Lifestyle Programbehavioral

Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.