Overview

This trial is active, not recruiting.

Condition obesity
Treatment exilis implantable gastric electrical stimulation (ges)
Sponsor Medtronic Corporate Technologies and New Ventures
Start date March 2013
End date January 2017
Trial size 30 participants
Trial identifier NCT01823705, Exilis-1

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Gastric Electrical Stimulation (GES) therapy for the treatment of obesity.
exilis implantable gastric electrical stimulation (ges) Exilis Implantable Gastric Electrical Stimulation

Primary Outcomes

Measure
Percent of subjects experiencing device-related serious adverse events (i.e., events requiring additional medical treatment).
time frame: 6 months
The level of gastrointestinal sensations, as rated on a 6-point ordinal scale during in-clinic testing, that corresponds to stimulation settings comfortable for chronic treatment.
time frame: 4 weeks

Secondary Outcomes

Measure
Change in gastric emptying time across a pair of in-clinic measurements made with and without GES.
time frame: 8 and 10 weeks
Change in caloric intake across a pair of standardized meals consumed in-clinic with and without GES.
time frame: 8 and 10 weeks
Change in body weight during chronic daily GES treatment.
time frame: Baseline and 6 months

Eligibility Criteria

Male or female participants from 21 years up to 64 years old.

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.

Additional Information

Official title Gastric Electrical Stimulation (GES) for the Treatment of Obesity
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic Corporate Technologies and New Ventures.