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

Primary Purpose

Obesity, Morbid

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

vBloc Maestro Rechargeable System

vBloc Achieve Weight Management Program

Control Weight Management (CWM) program

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Obesity, Bariatric surgery, Vagal blocking, vBloc therapy, Vagus Nerve, Percent excess weight loss, Percent total body weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

HonorHealth
Winthrop University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Observational arm

Randomized sub-study -Treatment

Randomized sub-study - Control

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03145636

First Posted

May 5, 2017

Last Updated

May 20, 2019

Sponsor

ReShape Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT03145636

Brief Title

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

Acronym

ReNEW

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 30, 2017 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ReShape Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Morbid

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Observational arm

Arm Type

Other

Arm Description

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

Arm Title

Randomized sub-study -Treatment

Arm Type

Other

Arm Description

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.

Arm Title

Randomized sub-study - Control

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

vBloc Maestro Rechargeable System

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

vBloc Achieve Weight Management Program

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control Weight Management (CWM) program

Intervention Description

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 Measure Information:

Title

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

Description

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Rate of therapy-related adverse events at 5 years

Description

To evaluate the long-term (5-year) rate of therapy-related adverse events

Time Frame

5 years

Title

Rate of device-related malfunction at 5 years

Description

To evaluate the long-term (5-year) rate of device (neuroregulator or lead) malfunction requiring a revision procedure

Time Frame

5 years

Title

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

Description

To evaluate the mean percentage excess weight loss (%EWL) through 5 years

Time Frame

5 years

Title

Percentage of subjects achieving at least 20 and 25%EWL thresholds through 5 years

Description

To evaluate the percentage of subjects achieving at least 20% EWL and 25% EWL through 5 years

Time Frame

5 years

Title

Mean percentage total body weight loss (%TBL) through 5 years

Description

To evaluate the mean percentage total body weight loss (%TBL) through 5 years

Time Frame

5 years

Title

Mean percentage of subjects achieving at least 5 and 10% TBL through 5 years

Description

To evaluate the percentage of subjects achieving at least 5% TBL and 10% TBL through 5 years

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles J Billington, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

HonorHealth

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Winthrop University Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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