NCT03145636

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: ReShape Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-30
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2017-05-09
• Last updated: 2019-05-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study