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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Maastricht, Netherlands
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).
Once adjudicated by the Adverse Events Advisory Committee (AEAC), all adverse events recorded during the study were tabulated and summarized by seriousness, intensity, and related. Device performance and use conditions where characterized by collecting data on amplitude settings and lead impedance recorded during device interrogations and conducted at each clinic visits. The data will be tabulated and summarized using descriptive statistics, but no hypotheses tests were pre-specified
Time frame: Duration of study
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.
In-clinic sensory testing and telephone follow-up were collected during Amplitude Titration phase and will be summarized. No formal hypothesis testing were pre-specified. Fourt separate visits were conducted approximately weekly during the titration phase. The testing procedure was expected to be repeated twice during each visits; once in a fasted state and once in a fed state. Subjects were asked to rate exposure sensitive from 0 (none) to 5 (intense)
Time frame: 4 weeks
Change in gastric emptying time across a pair of in-clinic measurements made with and without GES.
During the two GI function visits subjects completed the same set of acute tests on two separate days, once with GES On and once with GES Off. Treatment ordering was randomly assigned in a balanced fashion. Each testing visit was preceded by a one week GES Off washout period. The gastric emptying half time outcomes in the acute cross-over experiment will be analyzed using the repeated measures regression with fixed subject and test-day effects, with the model-based t-test for the difference in the marginal means of T1/2 across treatments being used for statistical inference.
Time frame: Screening, Week 26 and Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in whether GES delivered with the Exilis System suppresses post-meal gastric contractile activity
Antral motility index outcomes in the acute cross-over experiment were analyzed using the repeated measures regression with fixed subject and test-day effects. The model-based t-test for the difference in the marginal means of the MI values across treatments will be used for statistical inference.
Time frame: 8 and 10 weeks
Change in post-meal plasma glucose and insulin concentrations
Blood samples were collected in conjunction with the gastric emptying test meals to explore whether GES alters plasma levels of gut peptides involved in regulating food intake and body weight, including GLP-1, PP, and CCK.
Time frame: Baseline and 6 months
Changes in coloric intake during a standardized ad libitum solid meal consumed in a controlled setting
During the GI function tests in the acute-cross over experiments subjects were fed a macaroni and cheese meal in a controlled setting. the meal was given at each GI function visit once with GES On and once with GES Off. The caloric intake was measured during the visit to determine whether the GES On would reduce meal intake.
Time frame: 8 and 10 weeks
Change in physiological parameters, medication usage, and psychometric assessment scores that occur during chronic daily GES treatment with the Exilis System.
The values of physiological measures, psychometric assessment questionnaire scores and changes in these values from the Screening visit baseline will be summarized by visit using descriptive statistics. Medications will be categorized by their primary indications for use, and the proportion of subjects taking medications in each category and the mean number of medications in each category per subject will be calculated at each visit and plotted over time. No formal hypothesis testing will be conducted.
Time frame: Study duration