Status:
COMPLETED
Retrospective Independent Safety Review of Closed Irrisept Study
Lead Sponsor:
Irrimax Corporation
Conditions:
Adverse Events
Eligibility:
All Genders
Phase:
NA
Brief Summary
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...
Detailed Description
Between 2013 and 2016, Irrimax Corporation sponsored a prospective clinical study (IRR-CT-901-2013-01; NCT02255487) in the United States under IRB approval. IRR-CT-901-2013-01 defined primary and seco...
Eligibility Criteria
Inclusion
- Previously consented subjects from the closed study
- Subjects randomized to use Irrisept or SoC in the closed study
- Subjects who had a procedure in the hospital
- Subjects who used irrigation during the hospital procedure
- Subjects who had data that could be monitored and verified
Exclusion
- Subjects who did not meet all inclusion criteria
- The total number of subjects in this population - the mITT population - was 592.
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT05359666
Start Date
March 31 2020
End Date
November 29 2021
Last Update
August 14 2023
Active Locations (17)
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1
University of Arizona Department of Surgery
Tucson, Arizona, United States, 85724
2
Los Angeles County & USC Medical Center
Los Angeles, California, United States, 90033
3
Denver Health Medical Center
Denver, Colorado, United States, 80203
4
Tampa General Hospital University of South Florida (USF) College of Medicine
Tampa, Florida, United States, 33606