The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity (ReCharge)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01327976|
Recruitment Status : Unknown
Verified August 2017 by ReShape Lifesciences.
Recruitment status was: Active, not recruiting
First Posted : April 4, 2011
Results First Posted : May 27, 2016
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: vBloc (Active Device) Device: Sham (Non-active Device)||Not Applicable|
The Maestro® Rechargeable System is a neuromodulation system.
All subjects will be randomized in a 2:1 allocation to vBloc or Sham.
All subjects will be followed through the 12-month follow-up visit. Subjects in the Sham group who choose to have an active device will undergo a second surgery to receive the active device after study unblinding.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||January 2021|
Active Comparator: vBloc (Active Device)
The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period
Device: vBloc (Active Device)
Active device will deliver vBloc Therapy
Other Name: Maestro® Rechargeable System
Sham Comparator: Sham (Non-active Device)
The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period
Device: Sham (Non-active Device)
Functional non-active control device will deliver no vBloc Therapy
Other Name: Maestro® Rechargeable System
- Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs). [ Time Frame: 12 months ]To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.
- Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method. [ Time Frame: 12 months ]Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).
- Percentage Responder Rate in the Treatment Arm. [ Time Frame: 12 months ]The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327976
|United States, Arizona|
|HonorHealth (formerly Scottsdale Healthcare Bariatric Center)|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Scripps Clinic Nutrition & Metabolic Research Center|
|La Jolla, California, United States, 92037|
|Stanford, California, United States, 94305|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23219|
|Australia, New South Wales|
|Institute of Weight Control|
|Baulkham Hills, New South Wales, Australia|
|Adelaide Bariatric Centre|
|Bedford Park, SA, Australia|
|Principal Investigator:||Michael Sarr, M.D.||Mayo Clinic|
|Principal Investigator:||Charles Billington, M.D.||University of Minnesota|