At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss and/or Appetite Suppression
In Brief
A clinical study evaluating Transcutaneous Nerve Stimulator (TENS) and Diet & Exercise for Weight Loss. Completed, enrolled 161 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary. Behavioral: Diet \& Exercise Subjects to be instructed on a healthy 1200 calorie diet.
Subjects to be instructed on a healthy 1200 calorie diet.