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 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
NCT ID:
NCT01726257
Recruitment Details:
Up to 180 subjects will be enrolled at a maximum of 30 sites in the EU, and US in the Primary Investigation. This includes up to 30 Roll-in subjects and up to 150 patients in the Intent to Treat Pivotal Cohort. At enrollment closure for the Primary Investigation, an Extended Investigation will commence at these sites to enroll up to 250 additional subjects under continued access provisions. The protocol allowed up to 430 total subjects, however, the actual enrollment total was 333.
Study:
NCT01726257
Study Brief:
Results Section:
NCT01726257