The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol
NCT ID: NCT03145636
Last Updated: 2019-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4 participants
INTERVENTIONAL
2017-08-30
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Observational arm
Subjects will receive the device implant and use the vBloc Achieve Weight Management Program.
vBloc Maestro Rechargeable System
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
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.
vBloc Maestro Rechargeable System
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
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.
vBloc Maestro Rechargeable System
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
vBloc Achieve Weight Management Program
Remotely accessible web-based program to add additional support to subjects with vBloc therapy
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.
Interventions
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vBloc Maestro Rechargeable System
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
vBloc Achieve Weight Management Program
Remotely accessible web-based program to add additional support to subjects with vBloc therapy
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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ReShape Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Charles J Billington, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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HonorHealth
Scottsdale, Arizona, United States
Winthrop University Hospital
Mineola, New York, United States
Countries
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Other Identifiers
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D01569-000
Identifier Type: -
Identifier Source: org_study_id
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