EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- ReShape Lifesciences
- Enrollment
- 294
- Locations
- 15
- Primary Endpoint
- Percentage of Excess Weight Loss (EWL) With the Maestro System
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.
Detailed Description
The Maestro System is a neuromodulation system that consists of implantable and external components. Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator. External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned externally over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller. All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups. All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Excess Weight Loss (EWL) With the Maestro System
Time Frame: Baseline and 1 Year
Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
Rate of System and Procedure-related Serious Adverse Events (SAEs).
Time Frame: 1 Year
To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
Secondary Outcomes
- Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)(Baseline and 1 Year)