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NCT06489431 · ClinicalTrials.gov registry record · Phase 3
Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
A Phase 3 study of Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation, sponsored by Rush University Medical Center.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 3
- Study locations
NCT06489431 is a Phase 3 study of Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 200 participants, below the 226-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (12% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT06489431, a Phase 3 study of Erectile Dysfunction and Penile Prosthesis; Complications, Infection or Inflammation, is active but no longer recruiting, sponsored by Rush University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Rifampin
- DRUG Gentamicin
- DRUG Chlorhexidine
Study Locations (3)
Illinois
- Rush University Medical Center - Chicago
- Uropartners Surgery Center - Des Plaines
California
- Urological Surgeons of Northern California - Mountain View
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06489431
The ClinicalTrials.gov registry entry for NCT06489431 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 226-participant average among 33 other Erectile Dysfunction trials with a reported enrollment target (12% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Erectile Dysfunction appearing as the primary indexed condition, and to 3 interventions - of which Rifampin is the first listed.
NCT06489431 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Illinois, California.
Frequently Asked Questions
What is clinical trial NCT06489431 about?
NCT06489431 is a clinical study titled "Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement". 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.
What is the current status of trial NCT06489431?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2023-12-04. Estimated completion is 2027-12-31.
What conditions does trial NCT06489431 study?
This clinical trial studies the following conditions: Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation.
What interventions are being tested in trial NCT06489431?
The interventions under investigation include: Rifampin (DRUG), Gentamicin (DRUG), Chlorhexidine (DRUG).
Who is sponsoring clinical trial NCT06489431?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06489431 being conducted?
This trial has 3 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.