ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression (NCT03936699) | Clinical Trial Compass
CompletedNot Applicable
ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression
United States161 participantsStarted 2018-06-22
Plain-language summary
The objectives of this study are to demonstrate safety and effectiveness of a wearable patch TENS system (Appendix 2) in driving weight loss and appetite suppression when coupled with an integrated weight loss reduction strategy. The study is designed to demonstrate that TENS stimulation sufficient to drive weight loss and appetite suppression is safe and tolerable when compared to standard of care, and that adverse events/adverse device effects are similar to other TENS device use cases.
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
. Subject is between 18 - 65 years of age inclusive.
. Subject has a BMI of 25-35 kg/ m2 inclusive.
. Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
. Subject is able to wear and use a wearable, patch TENS system.
. Subject is able to use a touch screen hand held smart phone.
. Subject is fluent in English and can complete questionnaires.
. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening or enrollment visit, prior to placement of ELIRA 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
Number of Participants With Treatment Emergent Adverse Events
Timeframe: 12 weeks
2
Change in Appetite as Measured by a Visual Analogue Scale From Baseline
. 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.
Exclusion criteria
. Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial.
. Subject has had a prior bariatric procedure or any previous procedure on the stomach.
. Subject has any significant multisystem disease in the opinion of the PI.
. Subject has \> 6.5 HbA1c.
. Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
. Subject is a female of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
. Subject has current and/or a history of cancer within the past 5 years (not including basal cell carcinoma or cervical carcinoma in situ).