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

May 20, 2019 updated by: ReShape Lifesciences
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent
  2. Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more obesity related co-morbid conditions
  3. Females or males. Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
  4. At least 18 years of age
  5. Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last five years
  6. Ability to complete all study visits and procedures

Exclusion Criteria:

  1. Patients with cirrhosis of the liver, portal hypertension, or esophageal varices.
  2. Patients with a large (>5cm) symptomatic hiatal hernia
  3. Patients for whom magnetic resonance imaging (MRI) is planned
  4. Patients at high risk for surgical complications
  5. Patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators, neurostimulators)
  6. Patients for whom shortwave, microwave, or therapeutic ultrasound diathermy is planned Note: Diathermy is any treatment that uses high-frequency electromagnetic radiation, electric currents, or ultrasonic waves to produce heat in body tissues. Patients absolutely CANNOT be treated with any type of shortwave, microwave, or therapeutic ultrasound diathermy device whether or not it is used to produce heat. These treatments should not be applied anywhere on the body.
  7. Current medical condition that, in the opinion of the investigator, would make the subject unfit for surgery or that would be exacerbated by intentional weight loss. Some examples include diagnosis of cancer, recent heart attack, recent stroke or serious trauma.
  8. Recent cessation of cigarette smoking (prior 2 months)
  9. History of bariatric surgery, Nissen fundoplication, gastric resection, major upper-abdominal surgery, or other abdominal procedures at the discretion of the investigator (acceptable surgeries include cholecystectomy or hysterectomy)
  10. Patients with recent (<2 years) or current history of illicit drug abuse
  11. Patients with significant psychiatric disease including borderline personality disorder, psychosis, schizophrenia, unstable depression, suicidal ideation, or mental retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Observational arm
Subjects will receive the device implant and use the vBloc Achieve Weight Management Program.
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
Remotely accessible web-based program to add additional support to subjects with vBloc therapy
OTHER: Randomized sub-study -Treatment
Subjects will be randomly assigned (1:1) either to treatment or control. Treatment arm will receive the device and use of vBloc Achieve Weight Management Program.
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
Remotely accessible web-based program to add additional support to subjects with vBloc therapy
OTHER: Randomized sub-study - Control
Subjects will be randomly assigned (1:1) either to treatment or control. Control will participate in a Control Weight Management (CWM) program for 6 months prior to receiving the device implant and using the vBloc Achieve program.
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
Remotely accessible web-based program to add additional support to subjects with vBloc therapy
In person visits with Registered Dietician, or trained staff who will counsel subjects on energy balance, dietary intake, physical activity and eating behavior modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of device, therapy and procedure-related serious adverse events (SAEs)
Time Frame: 5 years
The primary safety objective is to show that the rate of serious adverse events (SAEs) related to the device, implant/revision procedure (including explant procedure), general surgical procedure, or therapy algorithm is statistically lower than 25% at 5 years.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of therapy-related adverse events at 5 years
Time Frame: 5 years
To evaluate the long-term (5-year) rate of therapy-related adverse events
5 years
Rate of device-related malfunction at 5 years
Time Frame: 5 years
To evaluate the long-term (5-year) rate of device (neuroregulator or lead) malfunction requiring a revision procedure
5 years
Mean percentage excess weight loss (%EWL) through 5 years
Time Frame: 5 years
To evaluate the mean percentage excess weight loss (%EWL) through 5 years
5 years
Percentage of subjects achieving at least 20 and 25%EWL thresholds through 5 years
Time Frame: 5 years
To evaluate the percentage of subjects achieving at least 20% EWL and 25% EWL through 5 years
5 years
Mean percentage total body weight loss (%TBL) through 5 years
Time Frame: 5 years
To evaluate the mean percentage total body weight loss (%TBL) through 5 years
5 years
Mean percentage of subjects achieving at least 5 and 10% TBL through 5 years
Time Frame: 5 years
To evaluate the percentage of subjects achieving at least 5% TBL and 10% TBL through 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charles J Billington, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2017

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (ACTUAL)

May 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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