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

This study is currently recruiting participants.
Verified December 2017 by EnteroMedics
Sponsor:
ClinicalTrials.gov Identifier:
NCT03145636
First Posted: May 9, 2017
Last Update Posted: December 5, 2017
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.
Information provided by (Responsible Party):
EnteroMedics
  Purpose
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. All subjects will participate in a weight management program, consisting of recommendations regarding diet, exercise, and behavior modification throughout the study.

Condition Intervention
Obesity, Morbid Device: vBloc Maestro Rechargeable System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol

Further study details as provided by EnteroMedics:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 200
Actual Study Start Date: August 30, 2017
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
vBloc Maestro Rechargeable System
All study subjects will be implanted with the vBloc Maestro Rechargeable System, and all will receive VBLOC therapy
Device: vBloc Maestro Rechargeable System
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity

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. After approval from the institutional review board, subjects will provide written consent and will receive a device implanted using laparoscopic placement of the leads and neuroregulator. Recommendations regarding diet, exercise, and behavior modification will be provided throughout the study. Weight, adverse events and other supportive measures are evaluated throughout the 60 month study duration.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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, suicide ideation, or mental retardation
  Contacts and Locations
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
  More Information

Responsible Party: EnteroMedics
ClinicalTrials.gov Identifier: NCT03145636     History of Changes
Other Study ID Numbers: D01569-000
First Submitted: May 5, 2017
First Posted: May 9, 2017
Last Update Posted: December 5, 2017
Last Verified: December 2017
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