NCT01327976

The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: ReShape Lifesciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control 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. After approval from the institutional review board, subjects provided written consent and were randomized in a 2 to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator) or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis. Both groups received similar diet and exercise counseling. Weight, adverse events, clinical laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout the 12 month study duration.

Detailed description

The Maestro® Rechargeable System is a neuromodulation system. All subjects will be randomized in a 2:1 allocation to vBloc or Sham. All subjects will be followed through the 12-month follow-up visit. Subjects in the Sham group who choose to have an active device will undergo a second surgery to receive the active device after study unblinding.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	vBloc (Active Device)	Active device will deliver vBloc Therapy
DEVICE	Sham (Non-active Device)	Functional non-active control device will deliver no vBloc Therapy

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-02-01
• Completion: 2021-01-01
• First posted: 2011-04-04
• Last updated: 2017-08-30
• Results posted: 2016-05-27

Locations

10 sites across 2 countries: United States, Australia