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First received: December 29, 2022

Clinical Trial: Safety & Effectiveness of TENS Weight Management Compared to a Sham

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Obesity, Mild

Study Type: INTERVENTIONAL


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

Brief 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

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