MedTrace Logo

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

NCT03145636 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-05-22

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • ReShape Lifesciences

    lead INDUSTRY

Principal Investigators

  • Charles J Billington, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-30
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03145636 on ClinicalTrials.gov