Clinical Research Directory
Browse clinical research sites, groups, and studies.
Emsella Chair vs Sham for Male Sexual Dysfunction
Sponsor: Corewell Health East
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
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