NCT02518685
Completed
Not Applicable
Endoscopic Treatment for Weight Reduction in Patients With Obesity Using the TransPyloric Shuttle® System: A Multicenter, Prospective, Randomized, Double-Blind, Sham-Controlled, Parallel-Design Study
ConditionsObesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- BaroNova, Inc.
- Enrollment
- 302
- Locations
- 9
- Primary Endpoint
- Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this clinical research trial is to study safety and effectiveness of the TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered medically obese.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects between the ages of 22 to 60
- •A BMI between 30.0 to 40.0 kg/m2, inclusive. Subjects with a BMI of 30.0 kg/m2 to 34.9 kg/m2 are required to have one or more obesity-related comorbidities
- •History of obesity for at least 2 years, with history of failure of medically or commercially supervised weight loss program
- •\< 5% change in body weight for at least 3 months
- •Negative pregnancy test, agree to be on birth control for the duration of participation
- •Informed consent
- •Willing and able to comply with study procedures
Exclusion Criteria
- •Pregnancy or nursing
- •Hormonal or genetic cause for obesity
- •Prior history of any GI surgery or endoscopic intervention
- •Chronic use of medications likely to contribute to weight gain or prevent weight loss
- •Gastric or duodenal ulcers
- •Positive for H. pylori
- •History of severe dyspepsia
- •GI tract motility disorders
- •History of inflammatory disease of GI tract, coeliac disease, pancreatitis, portal hypertension, cirrhosis, and/or varices
- •Diabetes treated with insulin
Outcomes
Primary Outcomes
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
Time Frame: 12 Months
The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
Time Frame: 12 months
The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
Study Sites (9)
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