Status:
COMPLETED
Gastric Electrical Stimulation (GES) for the Treatment of Obesity
Lead Sponsor:
Medtronic Corporate Technologies and New Ventures
Conditions:
Obesity
Eligibility:
All Genders
21-64 years
Phase:
NA
Brief Summary
The purpose of this feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are ...
Eligibility Criteria
Inclusion
- Adults ages 21-64 with BMI of 40-45 kg/m\^2 or BMI 35-39.9 kg/m\^2 with at least one obesity-related comorbidity, who have failed prior non-surgical weight loss attempts, and have been within 5% of their current weight for at least one year.
- If diabetic, subject has non-insulin-dependent type 2 diabetes mellitus diagnosed within the last 7 years, and has an HbA1c level less than 8%.
- If female and of child-bearing age, subject is not pregnant or lactating and is willing to use effective contraception for the duration of the study.
- Subject is willing and able to complete scheduled study visits, complete on-line lifestyle educational modules, and complete required procedures.
Exclusion
- Subject has a history of medical, surgical, or psychiatric conditions that, in the opinion of the Investigators, would limit study participation or contraindicate implantation of the Exilis GES system. Examples includes cardiac abnormalities contraindicating surgical anesthesia, prior gastrointestinal surgery, gastrointestinal motility disorders, inflammatory bowel disease, a history of eating disorders, anticipated future need for magnetic resonance imaging, or allergies to food ingredients in study test meals.
Key Trial Info
Start Date :
March 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01823705
Start Date
March 29 2013
End Date
January 13 2017
Last Update
October 2 2018
Active Locations (4)
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1
Scottsdale, Arizona, United States, 85258
2
Louisville, Kentucky, United States, 40202
3
Nashville, Tennessee, United States, 37232
4
Maastricht, Netherlands, 6229