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

NCT03145636 | Unknown DMC FDA Device

• 1 other identifier: D01569-000
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity, Morbid

Keywords

Obesity; Bariatric surgery; Vagal blocking; vBloc therapy; Vagus Nerve; Percent excess weight loss; Percent total body weight loss

Outcome Measures

Primary Outcomes (1)

• Rate of device, therapy and procedure-related serious adverse events (SAEs)

  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 Outcomes (6)

• Rate of therapy-related adverse events at 5 years

  5 years

• Rate of device-related malfunction at 5 years

  5 years

• Mean percentage excess weight loss (%EWL) through 5 years

  5 years

Study Arms (3)

Observational arm

OTHER

Subjects will receive the device implant and use the vBloc Achieve Weight Management Program.

Device: vBloc Maestro Rechargeable System; Other: vBloc Achieve Weight Management Program

Randomized sub-study -Treatment

OTHER

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; Other: vBloc Achieve Weight Management Program

Randomized sub-study - Control

OTHER

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; Other: vBloc Achieve Weight Management Program; Other: Control Weight Management (CWM) program

Interventions

vBloc Maestro Rechargeable System DEVICE

Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity

Observational arm; Randomized sub-study - Control; Randomized sub-study -Treatment

vBloc Achieve Weight Management Program OTHER

Remotely accessible web-based program to add additional support to subjects with vBloc therapy

Observational arm; Randomized sub-study - Control; Randomized sub-study -Treatment

Control Weight Management (CWM) program OTHER

In person visits with Registered Dietician, or trained staff who will counsel subjects on energy balance, dietary intake, physical activity and eating behavior modification.

Randomized sub-study - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ReShape Lifesciences: lead

Study Sites (2)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles J Billington, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: August 30, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)