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Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss

NCT03299881 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2021-11-10

Study results available
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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.

Conditions

Interventions

DEVICE

Transcutaneous Nerve Stimulator (TENS)

The Elira wearable patch system is a 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.

Sponsors & Collaborators

  • Elira Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Shelby Sullivan, MD · Consultant

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
2017-09-05
Primary Completion
2018-04-01
Completion
2018-04-01
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 NCT03299881 on ClinicalTrials.gov