EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

NCT00521079 | Completed Results DMC

• 1 other identifier: D00343-000
• Study Type: interventional
• Target: 294
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; Excess weight loss; Vagus nerve; Vagal blocking; vBloc(TM) therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Excess Weight Loss (EWL) With the Maestro System

  Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)

  Baseline and 1 Year

• Rate of System and Procedure-related Serious Adverse Events (SAEs).

  To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.

  1 Year

Secondary Outcomes (1)

• Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)

  Baseline and 1 Year

Study Arms (2)

vBloc

EXPERIMENTAL

Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).

Device: Therapy ON

Placebo

SHAM COMPARATOR

Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).

Device: Therapy OFF

Interventions

Therapy ON DEVICE

Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)

Also known as: Maestro System

vBloc

Therapy OFF DEVICE

Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)

Also known as: Maestro System

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 obesity related co-morbid condition. Co-morbid conditions may include one or more of the following:
• Hypertension as defined by systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg a) treated or untreated with systolic ≥140 mmHg or diastolic ≥90 mmHg or b) treated with systolic \<140 mmHg and diastolic \<90 mmHg
• Dyslipidemia as defined by total cholesterol ≥200 or LDL ≥130 a) treated or untreated with total cholesterol ≥200 or LDL ≥130 or b) treated with total cholesterol \<200 or LDL \<130
• Sleep apnea syndrome (confirmed by overnight p02 studies)
• Obesity related cardiomyopathy
• Females or males Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
• years of age inclusive.
• Type 2 diabetes mellitus subjects (at selected centers, limited to approximately 34 subjects) with:
• Glycosylated hemoglobin (Hb A1c) 6.5 - 9 % inclusive at screening visit.
• Onset: 10 years or less since initial diagnosis.
• Stable treatment regimen: no change in oral hypoglycemic treatment regimen within past 3 months.
• Currently not using insulin therapy, GLP-1 receptor agonists (e.g., exenatide), or DPP-4 inhibitors (e.g., sitagliptin) for diabetes treatment and have not been on these treatments in the past 6 months.
• Creatinine within normal reference range.
• No history of proliferative retinopathy.

You may not qualify if:

• 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 (acceptable surgeries include cholecystectomy, hysterectomy).
• History of pulmonary embolism or blood coagulation disorders.
• Current portal hypertension and/or esophageal varices.
• 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 (e.g., Prader-Willi Syndrome).
• Overall sustained reduction of more than 10% of body weight in the previous 12 months.
• Current type 1 diabetes mellitus (DM).
• Current or recent history (within 12 months) of ongoing bulimia.
• Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable).
• Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable).
• Current treatment for peptic ulcer disease (previous history acceptable).
• Chronic (more than 4 weeks of daily use) treatment with narcotic analgesic drug regimens (treatment with non-steroidal anti-inflammatory drugs acceptable).

Sponsors & Collaborators

• ReShape Lifesciences: lead

Study Sites (15)

HonorHealth (formerly Scottsdale Bariatric Center)

Scottsdale, Arizona, 85258, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Cleveland Clinic - Florida

Weston, Florida, 33331, United States

Location

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

Tufts New England Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic - Ohio

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Institute of Weight Control

Sydney, New South Wales, 2153, Australia

Location

Adelaide Bariatric Center - Flinders Private Hospital

Bedford Park, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Two confounding efficacy factors: Variable hours of therapy in both arms due to inconsistent external power source use and altered vagal excitability in the control arm due to small electrical inputs delivered to vagal nerves for safety checks.

Results Point of Contact

• Title: Senior Vice President of Clinical
• Organization: EnteroMedics Inc

ktweden@enteromedics.com

651-634-3209

Study Officials

• Charles J Billington, MD

  VA Medical Center, Minneapolis, MN / University of Minnesota

  PRINCIPAL INVESTIGATOR

• Michael Sarr, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 27, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: May 1, 2018
• Last Updated: August 24, 2018
• Results First Posted: February 20, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); AU (2)