N/A
Completed N=592
Retrospective Independent Safety Review of Closed Irrisept Study
Adverse Events
Source: ClinicalTrials.gov NCT05359666 ↗
Enrolled (actual)
592
Serious AEs
26.4%
Results posted
Aug 2023
Primary outcomePrimary: All Adverse Events — 894; 962 Adverse Events
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Adverse Events |
894; 962 | — |
| SECONDARY Subjects With Device-Related Adverse Events |
220; 194 | — |
| SECONDARY Number of Device-Related Adverse Events |
856; 952; 30; 5; 8; 5 | — |
| SECONDARY Number of Device Deficiencies |
0; 40; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
-Subjects who did not meet all inclusion criteria
The total number of subjects in this population - the mITT population - was 592.
Data sourced from ClinicalTrials.gov (NCT05359666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.