Gastric Electrical Stimulation (GES) for the Treatment of Obesity

Completed · Not applicable

Conditions studied: Obesity

In brief

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 comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to GES during in-clinic testing.

Key facts

Study ID

NCT01823705

Run by

Medtronic Corporate Technologies and New Ventures

People needed

32

Starts

2013-03-29

Expected to finish

2017-01-13

Last updated by the study team

2018-10-02

Who can join

Age: 21 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Louisville, Kentucky, United States
• Study site — Nashville, Tennessee, United States
• Study site — Maastricht, Netherlands

Full record on ClinicalTrials.gov

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