Obalon Balloon System Pivotal IDE (SMART) Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02235870

Run by

Obalon Therapeutics, Inc.

People needed

711

Starts

2015-02-01

Expected to finish

2016-05-01

Last updated by the study team

2018-03-08

Who can join

Age: 22 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

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
• Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities
• Type 1 diabetes
• Type 2 diabetes requiring insulin or other hypoglycemic oral agents.
• Experienced a myocardial infarction, has a known history of angina, a known history of congestive heart failure, or is currently being medically treated for any other cardiac condition
• Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic).
• End stage renal disease or requiring hemodialysis within the past 6 months
• Unwilling or unable to avoid Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Aspirin, Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study period
• Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying
• Subjects requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood
• Untreated or unstable alcohol or illicit drug addiction

Where it is running

• 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

Full record on ClinicalTrials.gov

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