EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

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.

Official Title

EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

Conditions

Obesity

Study Type

Interventional

Study Design

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• 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 Outcome Measures:

• 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]

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 trnasmits 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.

Study Start

August 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 65 Years
• Genders Eligible for Study: Both

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.

Total Enrolment

220

Contact Details

Adelaide Bariatric Center – Flinders Private Hospital, Bedford Park, South Australia, 5042, Australia; Recruiting

• Jane Collins: 011 61 8 8177 1503; Jane.Collins@fmc.sa.gov.au
• Mark Vollmer: 651-271-2691; mvollmer@enteromedics.com
• Russ Felkey: 651-634-3090; rfelkey@enteromedics.com