Overview

This trial is active, not recruiting.

Conditions obesity, overweight
Treatments active, implantable, intra abdominal vagal blocking medical device (maestro rc2 system)
Phase phase 3
Sponsor EnteroMedics
Start date May 2011
End date December 2012
Trial size 234 participants
Trial identifier NCT01327976, D01088

Summary

To determine the safety and efficacy of the Maestro RC2 System in producing weight loss in obese subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period
active, implantable, intra abdominal vagal blocking medical device (maestro rc2 system) Maestro RC2 System
Active device will deliver VBLOC Therapy
(Sham Comparator)
The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period
active, implantable, intra abdominal vagal blocking medical device (maestro rc2 system) Maestro RC2 System
Control device will deliver no VBLOC Therapy

Primary Outcomes

Measure
Primary efficacy objective
time frame: 12 months
Primary safety objective
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 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 severe obesity related co-morbid condition. - Females or males. - 18-65 years of age inclusive. - Type 2 diabetes mellitus subjects that are well-controlled. - Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last 5 yrs. - Ability to complete all study visits and procedures. Exclusion Criteria: - Concurrent chronic pancreatic disease. - History of Crohn's disease and/or ulcerative colitis. - History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery. - History of pulmonary embolism or blood coagulation disorders. - Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant. - Current portal hypertension and/or esophageal varices. - Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery. - Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial. - Smoking cessation within the prior six months. - Known genetic cause of obesity. - Overall sustained reduction of more than 10% of body weight in the previous 12 months. - Pre-operative diet with intent to lose weight prior to surgery.

Additional Information

Official title ReCharge Clinical Trial
Principal investigator Michael Sarr, M.D.
Description The Maestro RC2 System is a neuromodulation system. All subjects will be randomized in a 2:1 allocation to treatment or control group. All subjects will be followed through the 12-month follow-up visit. Subjects in the control group who choose to have an active device will undergo a second surgery.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by EnteroMedics.