Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06489431 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv8
  2. Collaborators revised (2)v7
  3. Enrollment target: 100 to 200
    • Study sites: 2 to 3
    • Collaborators: 1 to 2
    v6
  4. Trial status: Suspended to Active, Not Recruiting
    • Primary completion date: Dec 31, 2025 to May 31, 2026
    • Collaborators expanded, about 1 word
    v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Recruiting to Suspended Sponsor's reason: Currently suspending patient enrollment while IRB paperwork being reassigned and submitted
    • Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    • Site details revised at 2 of 2 sites
    v3
  2. Study sites: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.
Trial Details
NCT Number NCT06489431
Lead Sponsor Rush University Medical Center
Collaborators: Irrimaxcorp, Urological Surgeons of Northern California
Conditions
(from sponsor)		 Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation
Related terms Erectile Dysfunction, Infections, Inflammation
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov