What side effects are associated with this type of intervention?

Common treatments for obesity, including those similar to the Maestro Rechargeable System (vagal nerve blockade), often have side effects. Vagal nerve blockade can cause mild to moderate side effects such as nausea, vomiting, heartburn, and abdominal pain. Other obesity treatments like dietary interventions may lead to gastrointestinal distress, while medications such as orlistat can cause oily stools and flatulence. More invasive treatments like gastric balloons can result in nausea, vomiting, and abdominal discomfort. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity, including pharmacological agents and device-assisted therapies. Pharmacological treatments include drugs like orlistat, phentermine-topiramate, and liraglutide, which work through various mechanisms such as appetite suppression and fat absorption inhibition. Device-assisted therapies include the Maestro Rechargeable System, which uses vagal nerve blockade to reduce hunger sensations. This system represents a novel approach by targeting the nervous system to manage obesity, differing from traditional pharmacological methods.

What other types of research exist?

Promising novel alternatives to the Maestro Rechargeable System for obesity treatment in 2024 include: 1) GLP-1 receptor agonists such as semaglutide, which have shown significant weight loss in clinical trials; 2) Endoscopic sleeve gastroplasty, a minimally invasive procedure that reduces stomach size; 3) Bariatric surgery options like laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass, which remain highly effective for long-term weight loss; 4) Emerging neuromodulation techniques such as deep brain stimulation and transcranial magnetic stimulation, which are being explored for their potential in appetite regulation and weight loss.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver cirrhosis, portal hypertension, or esophageal varices.

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I have a large hiatal hernia causing symptoms.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Awards & 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.

0 / 5Eligibility criteria met

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.