NCT05675384

Safety & Effectiveness of TENS Weight Management Compared to a Sham

SAFETY AND EFFECTIVENESS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS)-ASSISTED WEIGHT MANAGEMENT (THE ELIRA SYSTEM) AS COMPARED TO A SHAM DEVICE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Elira, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

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. The objective is to demonstrate the effectiveness of the Elira System combined with a moderate intensity lifestyle therapy program compared to a sham device combined with a moderate intensity lifestyle therapy program control group at 3-months on weight management for participants who are overweight and/or with Class 1 obesity.

Conditions

• Obesity, Mild

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-29
• Primary completion: 2024-07-23
• Completion: 2024-07-23
• First posted: 2023-01-09
• Last updated: 2024-07-31

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study