Gastric Electrical Stimulation (GES) for the Treatment of Obesity

Medtronic

Status

Completed

Conditions

Obesity

Treatments

Device: Exilis Implantable Gastric Electrical Stimulation (GES)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01823705

Exilis-1

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

21 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.