SAFETY AND EFFECTIVENESS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS)-ASSISTED WEIGHT MANAGEMENT (THE ELIRA SYSTEM) AS COMPARED TO A SHAM DEVICE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Mild
- Sponsor
- Elira, Inc.
- Enrollment
- 395
- Locations
- 6
- Primary Endpoint
- A difference in Percent Total Body Weight Loss (%TBWL)
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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
Detailed Description
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. The objective is to demonstrate the effectiveness of the Elira System combined with a moderate intensity lifestyle therapy program compared to a sham device combined with a moderate intensity lifestyle therapy program control group at 3-months on weight management for participants who are overweight and/or with Class 1 obesity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is between 18 - 65 years of age inclusive.
- •Participant has a BMI of 25 to \< 35 kg/ m
- •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.
- •Participant agrees to adhere to diet \& exercise recommendations throughout study duration.
- •Participant is willing and able to adhere to assigned therapy throughout the study duration.
- •Participant has not participated in any clinical trial (except a registry) within the last 30 days.-
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.
- •Participant has had a weight change of ± 5% of his/her Total Body Weight in the 3 months prior to screening.
- •Participant has an uncontrolled psychiatric disorder.
Outcomes
Primary Outcomes
A difference in Percent Total Body Weight Loss (%TBWL)
Time Frame: Three Months
A difference in Percent Total Body Weight Loss (%TBWL) of greater than 0 (true mean percent of 2%) at 3-months in the Elira System (active) treatment group when compared to the sham (control) group who complete 3-months of treatment
A responder rate of at least 35% in the active treatment
Time Frame: Three Months
A responder rate of at least 35% in the active treatment participants who complete 3-months of treatment, calculated as the percentage achieving at least a 5% TBWL at 3-months
Secondary Outcomes
- Changes in appetite as measured by Appetite Visual Analogue Scale (VAS)(Three Months)
- Changes in BMI(Three Months)
- Changes in eating behaviors as measured by TFEQ scores(Three Months)
- Impact of weight on quality of life (IWQOL-Lite) scores(Three Months)