Retrospective Independent Safety Review of Closed Irrisept Study
Public ClinicalTrials.gov record NCT05359666. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol IRR-CT-901-2013-01)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of CLP-01 was to complete the safety endpoint of the closed trial and ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for and accurately identified, verified, and independently adjudicated. CLP-01 does not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01. CLP-01 did not enroll new subjects and relied solely on data collected in the subject source and medical records in IRR-CT-901-2013-01. CLP-01 was conducted between March 2020 and November 2021.
Study identification
- NCT ID
- NCT05359666
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 592 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2020 (Actual)
- Primary completion
- Nov 29, 2021 (Actual)
- Completion
- Nov 29, 2021 (Actual)
- Last update posted
- Aug 14, 2023
2020 – 2021
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Department of Surgery | Tucson | Arizona | 85724 | — |
| Los Angeles County & USC Medical Center | Los Angeles | California | 90033 | — |
| Denver Health Medical Center | Denver | Colorado | 80203 | — |
| Tampa General Hospital University of South Florida (USF) College of Medicine | Tampa | Florida | 33606 | — |
| University of Iowa Department of Surgery - 1504 JCP | Iowa City | Iowa | 52242 | — |
| University of Kentucky Department of Surgery | Lexington | Kentucky | 40536 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Baystate Medical Center Surgery Research, S3613 | Springfield | Massachusetts | 01199 | — |
| St. Louis University Department of Surgery | St Louis | Missouri | 63110 | — |
| University of Cincinnati Division of Trauma/Critical Care Department of Surgery | Cincinnati | Ohio | 45267 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38103 | — |
| University of Texas Southwestern (UTSW) Medical Center | Dallas | Texas | 75390 | — |
| University of Texas Health Science Center (UTHSC) at Houston Center for Translational Injury Research | Houston | Texas | 77030 | — |
| The University of Texas Health Center at San Antonio Division of Trauma and Emergency Surgery | San Antonio | Texas | 78229 | — |
| University of Washington Harborview Medical Center Department of Surgery | Seattle | Washington | 98104 | — |
| Medical College of Wisconsin Division of Trauma & Acute Care Surgery | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05359666, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 14, 2023 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05359666 live on ClinicalTrials.gov.