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Emsella Chair vs Sham for Male Sexual Dysfunction

Study acronym: Emsella_EJD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jul 2027 to Jul 2028
    • Study completion date: Dec 2027 to Dec 2028
    v13
  2. Primary completion date: Jul 2026 to Jul 2027
    • Study completion date: Jan 2027 to Dec 2027
    v12
  3. Enrollment target: 114 to 117v11
  4. Site contact updatedv10
  5. Study site revisedv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Jul 2025 to Jul 2026v8 Show 5 more changesShow less
    • Primary endpoint revised
    • Study completion date: Jan 2026 to Jan 2027
    • Secondary endpoints revised (11)
    • Site contact updated
    • Study description expanded, about 3 words
  2. Study site revisedv7
  3. Eligibility criteria shortened, about 42 words
    • Study description expanded, about 1 word
    v6
  4. Start date changed from estimate of Nov 2022 to Dec 14, 2022v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 15, 2022 to Nov 2022
    • Site details revised
    v4
  6. Eligibility criteria expanded, about 1 wordv3
  7. Start date: Jul 2022 to Oct 15, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05370651
Lead Sponsor Corewell Health East
Conditions
(from sponsor)		 Male Sexual Dysfunction, Ejaculatory Dysfunction
Related terms Ejaculatory Dysfunction
Enrollment 117 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov