The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity

NCT01327976 | Unknown Results DMC

• 1 other identifier: IDE G070025
• Study Type: interventional
• Target: 239
• Locations: 2 countries
• Sites: 10

Brief Summary

The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity. The Maestro Rechargeable System delivers intermittent, electrical blocking signals to the anterior and posterior trunks of the intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to reduce sensations of hunger and produce satiety leading to weight loss. After approval from the institutional review board, subjects provided written consent and were randomized in a 2 to 1 allocation to vBloc group (with laparoscopic placement of the leads and neuroregulator) or the sham group (placement of a custom sham neuroregulator only) on double-blinded basis. Both groups received similar diet and exercise counseling. Weight, adverse events, clinical laboratories, ECGs, eating questionnaires and quality of life data were evaluated throughout the 12 month study duration.

Conditions

Obesity

Keywords

Obesity; Bariatric surgery; Excess weight loss; Vagus nerve; Vagal blocking; vBloc Therapy

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).

  To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.

  12 months

• Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.

  Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).

  12 months

• Percentage Responder Rate in the Treatment Arm.

  The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.

  12 months

Study Arms (2)

vBloc (Active Device)

ACTIVE COMPARATOR

The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period

Device: vBloc (Active Device)

Sham (Non-active Device)

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

Device: Sham (Non-active Device)

Interventions

vBloc (Active Device) DEVICE

Active device will deliver vBloc Therapy

Also known as: Maestro® Rechargeable System

vBloc (Active Device)

Sham (Non-active Device) DEVICE

Functional non-active control device will deliver no vBloc Therapy

Also known as: Maestro® Rechargeable System

Sham (Non-active Device)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed 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 conditions. 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:
• Glycosylated hemoglobin (HbA1c) 7.0 - 10.0 % inclusive at screening visit. (Undiagnosed subjects that are found to have a HbA1c value between 7-10% at screening must see their primary physician for diagnosis and medical treatment before continuing in trial)
• Onset: 12 years or less since initial diagnosis.
• Currently not using insulin therapy, GLP-1 (glucagon-like peptide-1) receptor agonists (e.g., exenatide, liraglutide) 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.
• No history of peripheral neuropathy.

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.
• Clinically significant hiatal hernias (\> 5 cm) known from subject's medical record or determined by barium swallow (upper GI x-ray) or upper endoscopy per PI discretion prior to implant.
• Current cirrhosis, portal hypertension and/or esophageal varices.
• Treatment with prescription weight-loss drug therapy within the prior three months and the use of prescription drug therapy or the use of 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).
• Weight loss of more than 10% of body weight in the previous 12 months.
• Physician-prescribed diet with intent to lose weight prior to surgery (note:
• 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).

Sponsors & Collaborators

• ReShape Lifesciences: lead

Study Sites (10)

HonorHealth (formerly Scottsdale Healthcare Bariatric Center)

Scottsdale, Arizona, 85258, United States

Location

Scripps Clinic Nutrition & Metabolic Research Center

La Jolla, California, 92037, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Institute of Weight Control

Baulkham Hills, New South Wales, Australia

Location

Adelaide Bariatric Centre

Bedford Park, SA, Australia

Location

Related Publications (2)

• Apovian CM, Shah SN, Wolfe BM, Ikramuddin S, Miller CJ, Tweden KS, Billington CJ, Shikora SA. Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial. Obes Surg. 2017 Jan;27(1):169-176. doi: 10.1007/s11695-016-2325-7.

  PMID: 27506803 DERIVED

• Ikramuddin S, Blackstone RP, Brancatisano A, Toouli J, Shah SN, Wolfe BM, Fujioka K, Maher JW, Swain J, Que FG, Morton JM, Leslie DB, Brancatisano R, Kow L, O'Rourke RW, Deveney C, Takata M, Miller CJ, Knudson MB, Tweden KS, Shikora SA, Sarr MG, Billington CJ. Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial. JAMA. 2014 Sep 3;312(9):915-22. doi: 10.1001/jama.2014.10540.

  PMID: 25182100 DERIVED

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

Results Point of Contact

• Title: Director of Clinical Research
• Organization: EnteroMedics

mbroich@enteromedics.com

651-634-3209

Study Officials

• Michael Sarr, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Charles Billington, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: January 1, 2021
• Last Updated: August 30, 2017
• Results First Posted: May 27, 2016

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (8)