MedTrace Logo

ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression

NCT03936699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2022-02-02

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DEVICE

Transcutaneous Nerve Stimulator (TENS)

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.

BEHAVIORAL

Diet & Exercise

Subjects to be instructed on a healthy 1200 calorie diet.

Sponsors & Collaborators

  • Elira Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-22
Primary Completion
2019-05-30
Completion
2019-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936699 on ClinicalTrials.gov