Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-25 @ 2:08 PM
NCT ID:
NCT05359666
Pre Assignment Details:
CLP-01 included safety data only from trial IRR-CT-901-2013-01. There were 636 ITT subjects (i.e., those who consented into IRR-CT-901-2013-01). There were 592 mITT subjects (i.e., those who consented, randomized to Irrisept or SoC, had a procedure, used irrigation during that procedure \& had verifiable safety data. Of the 592 mITT subjects, 294 subjects were given Irrisept \& 298 subjects were given SOC. The remaining 44 subjects had non-evaluable data \& were not included in the analysis.
Recruitment Details:
CLP-01, a retrospective review study conducted between 03/2020 \& 11/2021, did not enroll new subjects, but relied solely on data collected for the trial IRR-CT-901-2013-01.CLP-01's purpose was to complete the safety endpoint of the closed trial \& ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for \& accurately identified, verified, \& independently adjudicated. CLP-01 did not include an evaluation of the efficacy or exploratory endpoints from IRR-CT-901-2013-01.
Study:
NCT05359666
Study Brief:
Results Section:
NCT05359666