Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT05359666
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05359666
Study Brief:
Protocol Section:
NCT05359666