ReCharge Clinical Trial - Full Text View

Purpose

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

Condition	Intervention	Phase
Obesity Overweight	Device: Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	ReCharge Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by EnteroMedics:

Primary Outcome Measures:

Primary efficacy objective [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Observe a 10% greater EWL from randomization with the Maestro System after 12 months of VBLOC Therapy compared to control by BMI method.

Observe clinically meaningful responder rates in the treatment arm of 20% and 25% EWL from implant at 12 months (not statistically based).
Primary safety objective [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
To demonstrate a 12 month Serious Adverse Event rate related to device, implant/revision and therapy of less than 15%.

Estimated Enrollment:	234
Study Start Date:	May 2011
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Device The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period	Device: Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System) Active device will deliver VBLOC Therapy Other Name: Maestro RC2 System
Sham Comparator: 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: Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System) Control device will deliver no VBLOC Therapy Other Name: Maestro RC2 System

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327976

Locations

United States, Arizona
Scottsdale Healthcare Bariatric Center
Scottsdale, Arizona, United States, 85258
United States, California
Scripps Clinic Nutrition & Metabolic Research Center
LaJolla, California, United States, 92037
Stanford University
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
Australia
Adelaide Bariatric Centre
Bedford Park, SA, Australia

Sponsors and Collaborators

EnteroMedics

Investigators

Principal Investigator:	Michael Sarr, M.D.	Mayo Clinic
Principal Investigator:	Charles Billington, M.D.	University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

Responsible Party:	EnteroMedics
ClinicalTrials.gov Identifier:	NCT01327976 History of Changes
Other Study ID Numbers:	D01088
Study First Received:	March 31, 2011
Last Updated:	April 12, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by EnteroMedics:

Obesity
Bariatric surgery
Excess weight loss

Vagus nerve
Vagal blocking
VBLOC Therapy

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013