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RECRUITING
NCT05370651
NA

Emsella Chair vs Sham for Male Sexual Dysfunction

Sponsor: Corewell Health East

View on ClinicalTrials.gov

Summary

We will be performing this study in 2 phases: Phase 1 will be an open label pilot study of 10 male participants. All participants in the pilot study will receive active treatment. If data from the pilot study is suggestive of symptom improvement, we will continue on to phase 2, which is a sham controlled, randomized blinded study. Participants in phase 2 will be randomized to receive either active treatment or sham. Potentially a total of 117 participants for both phases will be enrolled. The purpose of this study is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of sexual dysfunction, specifically erectile dysfunction (EjD) in men.

Official title: A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Male Sexual Dysfunction

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2022-12-14

Completion Date

2027-12

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DEVICE

BTL Emsella Chair

Subjects will sit on the device. The clinical research coordinator will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased until the subject reaches 100%.

Locations (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States