Overview

This trial is active, not recruiting.

Condition obesity
Treatment active, implantable, intra-abdominal vagal blocking medical device
Sponsor EnteroMedics
Start date August 2007
End date June 2013
Trial size 300 participants
Trial identifier NCT00521079, D00343-000

Summary

This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.

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, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects will be implanted with the Maestro System and are randomized to having VBLOC therapy ON.
active, implantable, intra-abdominal vagal blocking medical device Maestro System
Intermittent, programmable, intra-abdominal vagal blocking
(Placebo Comparator)
Subjects will be implanted with the Maestro System and are randomized to having VBLOC therapy OFF.
active, implantable, intra-abdominal vagal blocking medical device Maestro System
Intermittent, programmable, intra-abdominal vagal blocking

Primary Outcomes

Measure
To demonstrate a significantly greater percentage of excess weight loss with the Maestro System which provides VBLOC therapy.
time frame: 1 Year
To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
time frame: 1 Year

Secondary Outcomes

Measure
To demonstrate a significant difference between treatment groups in the proportion of subjects realizing at least a 25% excess weight loss from implant.
time frame: 1 Year

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 (at selected centers, limited to approximately 26 subjects). - Failure to respond to supervised diet/exercise program(s) in which the subject was engaged for at least 6 months. - 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 EMPOWER Clinical Trial: Vagal Blocking for Obesity Control
Principal investigator Charles J Billington, MD
Description The Maestro System is a neuromodulation system that consists of implantable and external components. Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator. External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller. All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups. All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by EnteroMedics.