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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01643733
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment.
* Subjects referred to us from the Dialysis units located in the study centres for clinically indicated fistulogram and fistula treatment.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures
Exclusion Criteria:
* Significant coagulopathy that cannot be adequately corrected.
* Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
* Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist and the referring nephrologist.
* Subjects who are uncooperative or cannot follow instructions.
* Mental state that may preclude completion of the study procedure or ability to obtain informed consent.
* Pregnant or nursing female subjects.
* Patients whose fistulae have never become functional.
* Patients with PTFE grafts/non-native fistulae
* Patients who have had previous stenting of fistulae
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
90 Years
Study:
NCT01643733
Study Brief:
Protocol Section:
NCT01643733