MedTrace Logo

Safety & Effectiveness of TENS Weight Management Compared to a Sham

NCT05675384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2024-07-31

No results posted yet for this study

Summary

This is a multicenter, randomized, blinded, parallel group, controlled study intended to evaluate the safety and effectiveness of treating overweight and Class 1 obese patients with the Elira System (TENS active treatment) combined with a moderate intensity lifestyle follow-up compared to participants using the sham (control) device combined with a moderate intensity lifestyle follow-up

Conditions

  • Obesity, Mild

Interventions

DEVICE

TENS Active Treatment

Using a 7-day/week wearable TENS device controlled by a Smart Phone App combined with moderate intensity lifestyle therapy,

DEVICE

Sham Device

Using the sham (control) device combined with a moderate intensity lifestyle follow-up

Sponsors & Collaborators

  • Elira, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2024-07-23
Completion
2024-07-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05675384 on ClinicalTrials.gov