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 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
NCT ID:
NCT00730327
Pre Assignment Details:
448 subjects were enrolled (defined as signing the informed consent), 44 of which were run-in subjects. Prior to randomization, 131 subjects were screen failures. 273 subjects were randomized to the BIB (137) and control groups (136). 12 BIB and 6 control subjects discontinued prior to treatment. 125 BIB and 130 control subjects began treatment.
Recruitment Details:
Patients were enrolled at 15 investigational sites across the US, between 6/20/2008 and 10/10/2010. Patients were either enrolled as run-in subjects (mentored cases which were enrolled prior to randomized subjects in order for physicians to gain experience with placing and removing the device) or as subjects for randomization.
Study:
NCT00730327
Study Brief:
Results Section:
NCT00730327