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:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT00341133
Eligibility Criteria:
* INCLUSION CRITERIA:
This research protocol is open to all participants with a known or suspected diagnosis of L-R axis malformations. Nationality or place of origin are not specific barriers to participation, provided that a blood or tissue sample can be safely sent by international FedEx (to be billed to our account).
Direct blood relatives (typicially parents, and occasionally affected siblings) of patients with L-R malformations are also eligible to participate.
EXCLUSION CRITERIA:
Anyone unwilling to provide informed consent (for themselves as adults, or on behalf of their children as minors) or assent.
Medical condition(s) are not in themselves reason for exclusion if in the judgment of the referring physician this would involve no more than minimal risk.
We generally review a brief clinical description from the referring physician about a potential research subject to determine that the subject is appropriate to enter into the study. We reserve the right to exclude cases that are clearly not related to our direct research interests (e.g. patients born with defects in the heart chambers, such as simple atrial or ventricular septal defects, would generally be excluded from this study).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00341133
Study Brief:
Protocol Section:
NCT00341133