Obalon Balloon System Pivotal IDE (SMART) Trial

NACompletedINTERVENTIONAL
Enrollment

711

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

November 30, 2015

Study Completion Date

May 31, 2016

Conditions
Obesity
Interventions
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.

Trial Locations (15)

Unknown

HonorHealth Research Institute, Scottsdale

Anaheim Clinical Trials, Anaheim

Southern California Research Center, Coronado

Bariatric Institute of Greater Chicago, Hinsdale

Endoscopic Microsurgery Associates, Towson

Saint Luke's Hospital of Kansas City, Kansas City

Washington University Hospital in St. Louis, St Louis

Stony Brook Medicine, Stony Brook

West Penn Hospital, Pittsburgh

Chattanooga Bariatrics, Chattanooga

Midsouth Bariatrics, Memphis

Vanderbilt University Medical Center, Nashville

Houston Methodist Research Institute, Houston

University of Utah Hospital, Salt Lake City

Virginia Mason Medical Center, Seattle

Sponsors
All Listed Sponsors
lead

Obalon Therapeutics, Inc.

INDUSTRY