Trials / Completed
CompletedNCT00200083
Study of Weight Loss Using Gastric Stimulation in Obese Patients
SHAPE: Screened Health Assessment & Pacer Evaluation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 190 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the effect of an implanted device that stimulates the stomach to help obese patients lose weight.
Detailed description
The purpose of this study was to evaluate efficacy and safety of the IGS system in a population of patients with a BMI between 35 and 55 kg/m2. SHAPE was a randomized, placebo-controlled, double-blind, multi-center pivotal study in which all subjects were implanted with the IGS system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcend II Model 8848 | All subjects will be implanted with the IGS device and then randomized to "on" or "off" for 12 months. After 12 months all subjects will be turned "on" through 24 month follow up. |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2005-09-01
- Completion
- 2008-01-01
- First posted
- 2005-09-20
- Last updated
- 2015-03-27
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00200083. Inclusion in this directory is not an endorsement.