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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant is between 18 - 65 years of age inclusive.
. Participant has a BMI of 25 to \< 35 kg/ m2.
. Participant has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
. Participant is able to use a touch screen handheld smart phone.
. Participant has Wi-Fi internet access for the duration of the study.
. Participant is fluent in English or Spanish and can complete questionnaires.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Participant agrees to adhere to diet \& exercise recommendations throughout study duration.
Exclusion criteria
. Participant has any known gastrointestinal disorder that in the opinion of the Investigator precludes enrollment into the trial.
. Participant has had a prior bariatric surgical procedure, endoscopic bariatric therapy, or surgery on the stomach.
. Participant has any significant multisystem disease in the opinion of the Investigator.
. Participant is a Type 2 diabetic.
. Participant has a history of significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
. Participant has an existing implanted electrical stimulator (e.g., pacemaker, AICD, cochlear implant).
. For female participants: planned pregnancy within 6 months from study start, active pregnancy, or currently breast feeding.
. 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.