Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- Elira Therapeutics, Inc.
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Treatment Emergent Adverse Events
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is a randomized, adaptive, parallel arm study. The treatment group will receive the Elira wearable patch system and provided instructions for use and advised to follow a 1200 calorie diet. The control group will be asked to follow a 12 calorie diet only. Each group will be followed for 12 weeks. Total body weight loss will be measured as well as appetite changes. Safety data will be collected throughout the study period. Safety and effectiveness will be determined based on differences between the groups.
Detailed Description
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. Enrollment will be up to 300 subjects at 4 US centers. After 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. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for women of childbearing age), and patient questionnaires will be collected. If eligible, subjects will be randomized to treatment or control groups. The treatment group will receive training on the Elira Wearable Patch System and the first TENS session will be administered in the investigators office. 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. All subjects will be required to have in office follow-up visits every 4 weeks for 12 weeks. Up to 2 additional follow-up visits will be permitted within that 12 week time period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is between 18 - 65 years of age inclusive.
- •Subject has a BMI of 25-35 kg/ m\^2 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 patient questionnaires.
- •Subject can comply with a 1200 calorie the recommended diet for the duration of the study.
- •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.
- •Females of childbearing potential must have a negative urine pregnancy test at enrollment visit, prior to placement of ELIRA device.
- •Exclusion Criteria
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Treatment Emergent Adverse Events
Time Frame: 12 weeks
Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).