The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol

NAUnknownINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 30, 2017

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Obesity, Morbid
Interventions
DEVICE

vBloc Maestro Rechargeable System

Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity

OTHER

vBloc Achieve Weight Management Program

Remotely accessible web-based program to add additional support to subjects with vBloc therapy

OTHER

Control Weight Management (CWM) program

In person visits with Registered Dietician, or trained staff who will counsel subjects on energy balance, dietary intake, physical activity and eating behavior modification.

Trial Locations (2)

11501

Winthrop University Hospital, Mineola

85258

HonorHealth, Scottsdale

Sponsors
All Listed Sponsors
lead

ReShape Lifesciences

INDUSTRY