Safety & Effectiveness of TENS Weight Management Compared to a Sham (NCT05675384) | Clinical Trial Compass
CompletedNot Applicable
Safety & Effectiveness of TENS Weight Management Compared to a Sham
United States395 participantsStarted 2022-07-29
Plain-language summary
This is a multicenter, randomized, blinded, parallel group, controlled study intended to evaluate the safety and effectiveness of treating overweight and Class 1 obese patients with the Elira System (TENS active treatment) combined with a moderate intensity lifestyle follow-up compared to participants using the sham (control) device combined with a moderate intensity lifestyle follow-up
Who can participate
Age range18 Years ā 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Participant is between 18 - 65 years of age inclusive.
ā. Participant has a BMI of 25 to \< 35 kg/ m2.
ā. Participant has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
ā. Participant is able to use a touch screen handheld smart phone.
ā. Participant has Wi-Fi internet access for the duration of the study.
ā. Participant is fluent in English or Spanish and can complete questionnaires.
ā. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening and enrollment visit and agree to using birth control to avoid pregnancy during the trial, prior to placement of assigned treatment device.
ā. Participant agrees to adhere to diet \& exercise recommendations throughout study duration.
Exclusion criteria
ā. Participant has any known gastrointestinal disorder that in the opinion of the Investigator precludes enrollment into the trial.
ā. Participant has had a prior bariatric surgical procedure, endoscopic bariatric therapy, or surgery on the stomach.
ā. Participant has any significant multisystem disease in the opinion of the Investigator.
ā
What they're measuring
1
A difference in Percent Total Body Weight Loss (%TBWL)
Timeframe: Three Months
2
A responder rate of at least 35% in the active treatment
ā. Participant has a history of significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
ā. Participant has an existing implanted electrical stimulator (e.g., pacemaker, AICD, cochlear implant).
ā. For female participants: planned pregnancy within 6 months from study start, active pregnancy, or currently breast feeding.
ā. Participant has current and/or a history of cancer with the exception of non-melanoma skin cancer or cervical carcinoma in situ \< 3 years before study enrollment.