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:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
NCT ID:
NCT03708393
Pre Assignment Details:
Breast mass images were acquired during PIONEER-01 study. The Reader-01 study-single arm, sequentially read (IUS vs. Imagio \[IUS+OA\]), controlled, blinded, multi-reader, multi-case (MRMC) feasibility study. New readers recruited; NO new subjects were recruited. Subject baseline, demographic and safety data comes from PIONEER-01 subjects who were randomly selected for Reader-01 study. Outcome measures compared IUS vs. IUS+OA. Truth based on biopsy diagnosis or 12 Mo F/U truth panel decision.
Recruitment Details:
New Independent Reader Feasibility Study (new readers re-reading a sub-set of randomly selected images acquired during PIONEER-01 Study (NCT01943916); Reader-01 study execution dates: 13 Nov 2018 to 6 Dec 2018
Study:
NCT03708393
Study Brief:
Results Section:
NCT03708393