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

Obesity, Morbid Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

This is a five-year, single arm, multi-center trial to evaluate the long-term safety and efficacy of the Maestro Rechargeable System in treating obesity. The study will include an observational arm and a randomized sub-study.

Clinical Trial Description

The study evaluates the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System for the treatment obesity. The Maestro Rechargeable System delivers intermittent, electrical blocking signals to the anterior and posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to reduce sensations of hunger and produce satiety leading to weight loss.

Subjects in the observational arm (100 subjects total) will receive the device implant and use the vBloc Achieve Weight Management Program.

The randomized sub-study (100 subjects) will randomly assign subjects (1:1) to either treatment (50 subjects) or control (50 subjects). The treatment arm will receive the device implant and use of the vBloc Achieve Weight Management Program. The control arm will participate in the Control Weight Management (CWM) during a 6 month period prior to receiving the device implant and using the vBloc Achieve program.

The vBloc Achieve Weight Management Program consists of recommendations regarding diet, exercise and behavior modification, and will be utilized by all subjects following their device implant. ;

Related Conditions & MeSH terms

• Obesity, Morbid

• NCT number: NCT03145636
• Study type: Interventional
• Source: ReShape Lifesciences
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 30, 2017
• Completion date: December 2024