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

NCT01327976 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2017-08-30

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ReShape Lifesciences

    lead INDUSTRY

Principal Investigators

  • Michael Sarr, M.D. · Mayo Clinic

  • Charles Billington, M.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-02-28
Completion
2021-01-31

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327976 on ClinicalTrials.gov