- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145636
The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol (ReNEW)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- HonorHealth
-
-
New York
-
Mineola, New York, United States, 11501
- Winthrop University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent
- 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
- 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.
- At least 18 years of age
- Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last five years
- Ability to complete all study visits and procedures
Exclusion Criteria:
- Patients with cirrhosis of the liver, portal hypertension, or esophageal varices.
- Patients with a large (>5cm) symptomatic hiatal hernia
- Patients for whom magnetic resonance imaging (MRI) is planned
- Patients at high risk for surgical complications
- Patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators, neurostimulators)
- 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.
- 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.
- Recent cessation of cigarette smoking (prior 2 months)
- 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)
- Patients with recent (<2 years) or current history of illicit drug abuse
- Patients with significant psychiatric disease including borderline personality disorder, psychosis, schizophrenia, unstable depression, suicidal ideation, or mental retardation
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Charles J Billington, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D01569-000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Obesity, Morbid
-
ClinTrio Ltd.UnknownMorbid Obesity Requiring Bariatric SurgeryBelgium, Germany, Portugal, Austria, Netherlands, Poland, Saudi Arabia
-
Centre Hospitalier Universitaire de NiceCompletedMorbid Obesity D009765France
-
Shanghai Jiao Tong University School of MedicineUnknown
-
Hospices Civils de LyonCentre de Recherche en Nutrition Humaine Rhone-Alpe; Institut National de Recherche... and other collaboratorsRecruiting
-
Endolumik, IncWest Virginia UniversityNot yet recruitingMorbid ObesityUnited States
-
Rijnstate HospitalRecruiting
-
Laval UniversityCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie...Recruiting
-
University of WashingtonUnited States Department of DefenseWithdrawn
-
Helsinki University Central HospitalActive, not recruiting
-
IHU StrasbourgWithdrawnMorbid Obesity
Clinical Trials on vBloc Maestro Rechargeable System
-
ReShape LifesciencesUnknownObesityUnited States, Australia
-
Lepu Medical Technology (Beijing) Co., Ltd.Recruiting
-
ReShape LifesciencesCompletedObesityUnited States, Australia
-
Lorillard Tobacco CompanyCompleted
-
Abbott Medical DevicesWithdrawnHeart FailureFrance
-
Beijing Pins Medical Co., LtdBeijing Tiantan HospitalUnknown