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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
Must not have
Patients with cirrhosis of the liver, portal hypertension, or esophageal varices
Patients with a large (>5cm) symptomatic hiatal hernia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a device called the Maestro Rechargeable System, which helps people with obesity feel less hungry by sending electrical signals to a nerve in their stomach. This helps them eat less and lose weight. The device has shown promising results in weight loss and blood sugar control in previous studies.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can attend all required study visits and procedures.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have liver cirrhosis, portal hypertension, or esophageal varices.
Select...
I have a large hiatal hernia causing symptoms.
Select...
I am not planning to undergo any heat treatments like diathermy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of device, therapy and procedure-related serious adverse events (SAEs)
Other study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Maestro Rechargeable System, which uses vagal nerve blockade, works by intermittently blocking the vagus nerve, which plays a key role in regulating hunger and satiety signals between the brain and the stomach. This can help reduce appetite and food intake, leading to weight loss.
Other common treatments for obesity include GLP-1 receptor agonists like liraglutide and semaglutide, which enhance insulin secretion, slow gastric emptying, and promote satiety. Pharmacologic options such as combination phentermine-topiramate and bupropion-naltrexone work by suppressing appetite and increasing energy expenditure.
Bariatric surgery, including gastric bypass and sleeve gastrectomy, physically restricts stomach size and alters gut hormones to reduce hunger and improve satiety. These treatments are crucial for obesity patients as they address the complex physiological mechanisms underlying obesity, helping to achieve significant and sustained weight loss, which is essential for improving overall health and reducing the risk of obesity-related complications.
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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
Research Study Groups:
This trial has the following groups:- Group 1: Randomized sub-study - Control
- Group 2: Observational arm
- Group 3: Randomized sub-study -Treatment