ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

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.
    

Detailed description: 
      Randomized, adaptive parallel arm study. Subjects will be initially screened during a
      screening period (+/- 7 days). During this screening period, subjects will sign an Informed
      Consent Form (ICF), have their weight/height and blood pressure measured as part of a
      physical exam, take a pregnancy test (females of child bearing potential), get blood drawn
      for analysis (blood lipids, HbA1c), and complete the PHQ-9 and pre-study survey.

      At the end of the screening period, eligible subjects will be enrolled/randomized in the
      study and be randomized to either a treatment or control group. After enrolling, both control
      and treatment subjects will be instructed to follow a healthy diet and reduce calories as
      desired for the duration of the study and will receive training on the use of the electronic
      scale and completion of paper diaries. For the treatment group, subjects will be instructed
      on use of the Elira wearable patch system. Photographs will be taken at the enrollment visit.
      Following this, subjects will enter the Therapy Period for ~24-weeks.

      At the 12 week visit, subjects will be assessed for weight loss, blood pressure, blood
      lipids, HbA1c, patient preference questionnaire and their participation will continue through
      months 4-6 for the Safety phase of the Therapy Period. The Therapy Period will be considered
      complete (pending laboratory results, adverse events or serious adverse events). Patient
      (treatment) photographs will also be taken at the 12 week visit.

      The study utilizes an adaptive approach where cohorts of enrolled/randomized subjects (in
      groups of ~25 per arm) are assessed for dose response and progression to achievement of
      primary and secondary endpoints. Frequent interim endpoint assessment utilizing Markov-chain
      Monte Carlo (MCMC) methods coupled with Longitudinal analyses will be utilized to determine
      sample sizes for future cohorts (assessed primarily via Normal dynamic linear modeling
      [NDLM]). Long term safety of the device will be shown through 6 months of usage.
    

Intervention name(s): Transcutaneous Nerve Stimulator (TENS); Diet & Exercise
Intervention type(s): Device; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, adaptive parallel arm study.
Masking: None (Open Label)
Primary purpose: Treatment