ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03145636
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
EnteroMedics

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Device: vBloc Maestro Rechargeable System Other: vBloc Achieve Weight Management Program Other: Control Weight Management (CWM) program Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Observational arm
Subjects will receive the device implant and use the vBloc Achieve Weight Management Program.
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

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.
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

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.
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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145636


Locations
United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Heather Lane    480-323-3000    Heather.Lane@HonorHealth.com   
Principal Investigator: James Swain, MD         
United States, California
Smart Dimensions Weight Loss Recruiting
Fountain Valley, California, United States, 92708
Contact: Richard Hoang, PA    714-861-4666    rhoang0814@hotmail.com   
Principal Investigator: Peter C LePort, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Chris Eagon, MD    314-362-5000    eagonc@wustl.edu   
Principal Investigator: J C Eagon, MD         
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Karen Norowski, RN    855-358-6907    knorowski@winthrop.org   
Principal Investigator: Colin Brathwaite, MD         
Sponsors and Collaborators
EnteroMedics
Investigators
Principal Investigator: Charles J Billington, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: EnteroMedics
ClinicalTrials.gov Identifier: NCT03145636     History of Changes
Other Study ID Numbers: D01569-000
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by EnteroMedics:
Obesity
Bariatric surgery
Vagal blocking
vBloc therapy
Vagus Nerve
Percent excess weight loss
Percent total body weight loss

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms