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Emsella Chair vs Sham for Male Sexual Dysfunction

NCT05370651 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

  • Male Sexual Dysfunction
  • Ejaculatory Dysfunction

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%.

Sponsors & Collaborators

  • Corewell Health East

    lead OTHER

Principal Investigators

  • Kenneth Peters, MD · Corewell Health William Beaumont University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05370651 on ClinicalTrials.gov