NCT00521079

EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: ReShape Lifesciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Therapy ON	Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)
DEVICE	Therapy OFF	Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-10-01
• Completion: 2018-05-01
• First posted: 2007-08-27
• Last updated: 2018-08-24
• Results posted: 2017-02-20

Locations

15 sites across 2 countries: United States, Australia