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Device

vBloc Therapy for Obesity (ReNEW Trial)

N/A
Waitlist Available
Led By Charles J Billington, MD
Research Sponsored by ReShape Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Ability to complete all study visits and procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

ReNEW Trial Summary

This trial will test the long-term safety and effectiveness of a weight-loss device called the Maestro Rechargeable System. The study will last for five years, and will include both an observational group and a group of people who will be randomly assigned to use the device.

Who is the study for?
This trial is for adults with obesity who have a BMI of 40-45, or 35-39.9 with related health issues, and haven't had success with diet/exercise in the past five years. Women must test negative for pregnancy and use contraception. Exclusions include those with certain medical conditions like large hernias, drug abuse, liver cirrhosis, psychiatric diseases, high surgical risk or those needing MRI or diathermy treatments.Check my eligibility
What is being tested?
The ReNEW Study tests the Maestro Rechargeable System's safety and effectiveness in treating obesity over five years. Participants will also follow the vBloc Achieve Weight Management Program compared to a Control Weight Management program within an observational arm and randomized sub-study.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with surgical procedures (like infection), device-specific complications (such as malfunctioning), and general discomforts from lifestyle changes due to weight management programs.

ReNEW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can attend all required study visits and procedures.

ReNEW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of device, therapy and procedure-related serious adverse events (SAEs)
Other outcome measures
Mean percentage excess weight loss (%EWL) through 5 years
Mean percentage of subjects achieving at least 5 and 10% TBL through 5 years
Mean percentage total body weight loss (%TBL) through 5 years
+3 more

ReNEW Trial Design

3Treatment groups
Experimental Treatment
Group I: Randomized sub-study -TreatmentExperimental Treatment2 Interventions
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.
Group II: Randomized sub-study - ControlExperimental Treatment3 Interventions
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.
Group III: Observational armExperimental Treatment2 Interventions
Subjects will receive the device implant and use the vBloc Achieve Weight Management Program.

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Who is running the clinical trial?

ReShape LifesciencesLead Sponsor
10 Previous Clinical Trials
1,411 Total Patients Enrolled
9 Trials studying Obesity
1,286 Patients Enrolled for Obesity
Charles J Billington, MDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
294 Total Patients Enrolled
1 Trials studying Obesity
294 Patients Enrolled for Obesity

Media Library

Obesity Research Study Groups: Randomized sub-study - Control, Observational arm, Randomized sub-study -Treatment

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the opportunity to participate in this trial currently available for individuals?

"According to the record on clinicaltrials.gov, this particular medical trial is not presently accepting patients. It was first posted on August 30th 2017 and last updated May 20th 2019; however, there are 95 other trials which are open for recruitment at this moment in time."

Answered by AI

Who else is applying?

What state do they live in?
New York
Arizona
What site did they apply to?
Winthrop University Hospital
HonorHealth
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
2
3+

Why did patients apply to this trial?

I'm tired of taking medications that help with weight loss so I want to explore other options.
PatientReceived 2+ prior treatments
I've tried dieting. I also tried a clinical trial with noom last year. I keep gaining weight. I'm desperate to find something that works.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

This sounds invasive, how long will I be down? How often do I need to visit the clinic and what does the trial pay?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol
2017. "The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03145636.
All > Morbid Obesity
~0 spots leftby Dec 2024
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