Obesity, MorbidReNEWNCT03145636
The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol
A study testing vBloc Maestro Rechargeable System and vBloc Achieve Weight Management Program in people with Obesity, Morbid, run by ReShape Lifesciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- vBloc Maestro Rechargeable System and vBloc Achieve Weight Management Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2017to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Winthrop University Hospital
Mineola, New York, 11501
HonorHealth
Scottsdale, Arizona, 85258
About this study
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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- vBloc Maestro Rechargeable System, vBloc Achieve Weight Management Program, Control Weight Management (CWM) program
- Keywords
- Obesity, Bariatric surgery, Vagal blocking, vBloc therapy, Vagus Nerve, Percent excess weight loss, Percent total body weight loss
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vBloc Maestro Rechargeable SystemDevice
Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
vBloc Achieve Weight Management ProgramOther
Remotely accessible web-based program to add additional support to subjects with vBloc therapy
Control Weight Management (CWM) programOther
In person visits with Registered Dietician, or trained staff who will counsel subjects on energy balance, dietary intake, physical activity and eating behavior modification.
| Study group | Role | What they receive |
|---|---|---|
| Observational arm | Other | Subjects will receive the device implant and use the vBloc Achieve Weight Management Program. Receives: 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. Receives: 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. Receives: Device: vBloc Maestro Rechargeable System; Other: vBloc Achieve Weight Management Program; Other: Control Weight Management (CWM) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start30 Aug 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles J Billington, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145636
- Sponsor's protocol ID
- D01569-000
- Acronym
- ReNEW
- Status last verified
- May 2019
- First submitted
- 5 May 2017
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol
- ClinicalTrials.gov ID
- NCT03145636
- Acronym / sponsor ID
- ReNEW / D01569-000
- Conditions
- Obesity, Morbid
- Keywords
- Obesity, Bariatric surgery, Vagal blocking, vBloc therapy, Vagus Nerve, Percent excess weight loss, Percent total body weight loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (actual)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational arm | Other | Device: vBloc Maestro Rechargeable System, Other: vBloc Achieve Weight Management ProgramSubjects will receive the device implant and use the vBloc Achieve Weight Management Program. |
| Randomized sub-study -Treatment | Other | Device: vBloc Maestro Rechargeable System, Other: vBloc Achieve Weight Management ProgramSubjects 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. |
| Randomized sub-study - Control | Other | Device: vBloc Maestro Rechargeable System, Other: vBloc Achieve Weight Management Program, Other: Control Weight Management (CWM) programSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vBloc Maestro Rechargeable SystemIntra-abdominal vagal blocking neuromodulation device for the treatment of obesity | Device | Observational arm, Randomized sub-study - Control, Randomized sub-study -Treatment |
| vBloc Achieve Weight Management ProgramRemotely accessible web-based program to add additional support to subjects with vBloc therapy | Other | Observational arm, Randomized sub-study - Control, Randomized sub-study -Treatment |
| Control Weight Management (CWM) programIn person visits with Registered Dietician, or trained staff who will counsel subjects on energy balance, dietary intake, physical activity and eating behavior modification. | Other | Randomized sub-study - Control |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles J Billington, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vBloc Maestro Rechargeable System and vBloc Achieve Weight Management Program in people with Obesity, Morbid, run by ReShape Lifesciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device, therapy and procedure-related serious adverse events (SAEs) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019; AzTrials last refreshed its copy on 27 Oct 2026.