Obalon Balloon System Pivotal IDE (SMART) Trial
SMART
The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial
1 other identifier
interventional
711
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Feb 2015
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
March 8, 2018
CompletedMarch 8, 2018
February 1, 2018
9 months
September 8, 2014
June 28, 2017
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin
24 Weeks
Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%
6 months
Other Outcomes (1)
Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group
6 Months
Study Arms (2)
Treatment Group
ACTIVE COMPARATORIn accordance with the randomization assignment, treatment arm subjects will receive a 6-month course of Balloon therapy with a nutrition and lifestyle program. Balloon treatment consists of placement of 3 balloons Obalon Intragastric Balloons in the first 3 months of therapy.
Control Group
SHAM COMPARATORControl arm subjects will receive a single 6-month course of sham device therapy with a nutrition and lifestyle program. Sham treatment consists of placement of 3 shams in the first 3 months of therapy.
Interventions
Intragastric Balloon System to aid in portion control.
Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.
Eligibility Criteria
You may qualify if:
- Male or female between the ages of 22-64 years
- Current BMI of 30.0 - 40 kg/m2
- Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet
- Willing to attend all protocol-specified follow-up visits plus any additional follow-up visits as required throughout the entire study period
- Willing to avoid non-commercial air travel and scuba diving during the entire study period
- Willing to avoid medications or other substances known to effect weight changes during the study
- Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications known to be gastric irritants during the study
- Willing to use contraception and avoid pregnancy during the study if the subject is female with child bearing potential
- Willing to provide written informed consent
You may not qualify if:
- Significant weight loss in the past 12 months
- Use of medications or other substances known to induce weight gain or weight loss
- Participation in any clinical study at the start of this trial or in the last year
- Known history of endocrine disorders affecting weight
- Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV
- Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders
- Intent to undergo gastric surgery or gastric banding during the study period or within the 6 month period after completion of this study
- Prior use of any weight loss medical device
- Known history of structural or functional disorders of the esophagus
- Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
- Known history of structural or functional disorders of the stomach
- Known history of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety
- Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract
- Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
- Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Midsouth Bariatrics
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Methodist Research Institute
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Virginia Mason Medical Center
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amy VandenBerg, Vice-President, Clinical Affairs and Regulatory Affairs
- Organization
- Obalon Therapeutics, Inc.
Study Officials
- STUDY CHAIR
Amy VandenBerg
Obalon Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2014
First Posted
September 10, 2014
Study Start
February 1, 2015
Primary Completion
November 1, 2015
Study Completion
May 1, 2016
Last Updated
March 8, 2018
Results First Posted
March 8, 2018
Record last verified: 2018-02