#STIMULATOR TENS PATCH#
#STIMULATOR TENS TRIAL#

Subject has any significant multisystem disease in the opinion of the PI.Subject has had a prior bariatric procedure.Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial.Females of childbearing potential must have a negative urine pregnancy test at enrollment visit, prior to placement of ELIRA device.

#STIMULATOR TENS TRIAL#

Subject is male or non-pregnant, non-lactating female, who agrees to use effective contraceptive methods throughout the length of the trial based on PI approval.Subject can comply with a 1200 calorie the recommended diet for the duration of the study.Subject is fluent in English and can complete patient questionnaires.Subject is able to use a touch screen hand held smart phone.

#STIMULATOR TENS PATCH#

Subject is able to wear and use a wearable, patch TENS system.

Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.

Subject has a BMI of 25-35 kg/ m^2 inclusive.

Subject is between 18 - 65 years of age inclusive.

Up to 2 additional follow-up visits will be permitted within that 12 week time period. All subjects will be required to have in office follow-up visits every 4 weeks for 12 weeks. Both groups will receive an electronic scale and instructions on 1200 calorie diet as well as diary completion requirements to be completed throughout the study. The treatment group will receive training on the Elira Wearable Patch System and the first TENS session will be administered in the investigators office.

If eligible, subjects will be randomized to treatment or control groups. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for women of childbearing age), and patient questionnaires will be collected. Enrollment will be up to 300 subjects at 4 US centers.Īfter signing informed consent, subjects will be screened during a one week screening/baseline period to determine if they meet the inclusion criteria and exhibit none of the exclusion criteria. This study employs a randomized, adaptive, parallel arm study in which, cohorts of enrolled subjects (25 per arm) are assessed for dose response and progression to achievement of primary and secondary endpoints.

Why Should I Register and Submit Results?.

Stimulator tens