Status:
COMPLETED
Obalon Balloon System Pivotal IDE (SMART) Trial
Lead Sponsor:
Obalon Therapeutics, Inc.
Conditions:
Obesity
Eligibility:
All Genders
22-64 years
Phase:
NA
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-mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Known history of allergies to any component of the device materials
- Currently pregnant or breastfeeding or intention of becoming pregnant during the study
- Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
- Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff
- Subject is a close relative of another subject already enrolled in the study.
- Any other condition that, in the opinion of the investigator, would interfere with subject participation, may confound the study results, or interfere with compliance with the study (e.g., psychosocial issues).
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
711 Patients enrolled
Trial Details
Trial ID
NCT02235870
Start Date
February 1 2015
End Date
May 1 2016
Last Update
March 8 2018
Active Locations (15)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States
2
Anaheim Clinical Trials
Anaheim, California, United States
3
Southern California Research Center
Coronado, California, United States
4
Bariatric Institute of Greater Chicago
Hinsdale, Illinois, United States