Clinical trial NCT01823705: Gastric Electrical Stimulation (GES) for the Treatment of Obesity
Official title: Gastric Electrical Stimulation (GES) for the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Medtronic Corporate Technologies and New Ventures
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: First-in-human experience with the Exilis System, including initial clinical feasibility and safety data, as well as data on device performance (e.g., recharge durations and intervals) and use conditions (e.g., stimulation amplitudes, lead impedances).
timeFrame: Duration of study
measure: To gain an understanding of what sensations, if any, subjects feel during GES treatment, and what level and type of sensations subjects find acceptable and comfortable during chronic daily treatment.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in gastric emptying time across a pair of in-clinic measurements made with and without GES.
timeFrame: Screening, Week 26 and Week 52
measure: Change in whether GES delivered with the Exilis System suppresses post-meal gastric contractile activity
timeFrame: 8 and 10 weeks
measure: Change in post-meal plasma glucose and insulin concentrations
timeFrame: Baseline and 6 months
measure: Changes in coloric intake during a standardized ad libitum solid meal consumed in a controlled setting
timeFrame: 8 and 10 weeks
measure: Change in physiological parameters, medication usage, and psychometric assessment scores that occur during chronic daily GES treatment with the Exilis System.
timeFrame: Study duration
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Louisville
country: United States
state: Kentucky
city: Nashville
country: United States
state: Tennessee
city: Maastricht
country: Netherlands
Study officials:
References: