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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT03779906
Pre Assignment Details:
Pediatric subjects (0-3 years of age) scheduled to undergo a routine radiologic procedure with intravascular administration of ISOVUE who had normal TFTs (serum TSH, T3, T4 \& fT4) at baseline were to be enrolled. TFTs were to be reassessed at 1 month and 2 months post-ISOVUE injection. If TSH values were abnormal at 1- or 2-months, follow-up (via pre-defined questionnaire) was required at 6 and 12 months to monitor subject's progress (if any). Efficacy of ISOVUE was not assessed.
Recruitment Details:
On 03 March 2022, Food and Drug Administration (FDA) released Bracco from the Post-Marketing Requirement (PMR) commitment as the risk of thyroid dysfunction was adequately addressed by FDA's review of findings reported in currently available publications. Therefore, the study was terminated on 25 March 2022 with only 17 subjects enrolled and dosed.
Study:
NCT03779906
Study Brief:
Results Section:
NCT03779906