Trial record 2 of 7 for:
recharge
ReCharge Clinical Trial
This study is ongoing, but not recruiting participants.
Sponsor:
EnteroMedics
Information provided by (Responsible Party):
EnteroMedics
ClinicalTrials.gov Identifier:
NCT01327976
First received: March 31, 2011
Last updated: April 12, 2012
Last verified: April 2012
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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 |
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327976
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 by EnteroMedics
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
ClinicalTrials.gov processed this record on March 03, 2015