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:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT02006303
Eligibility Criteria:
Inclusion Criteria:
1. Male subjects, over 50 years of age at the time of enrollment.
2. Subjects referred to urology for BPH leading to permanent indwelling bladder catheters and are considered poor surgical candidates
3. Written informed consent to participate in the study.
4. Ability to comply with the requirements of the study procedures
Exclusion Criteria:
1. Previous surgical treatment for BPH
2. Presence of bladder stones
3. History of prostate cancer
4. Prostate size \> 150 g
5. History of urethral stenosis or its management
6. Known of suspected neurogenic bladder
7. History of recent hematochezia in the last 3 months
8. Contraindication to intravascular iodinated contrast such as allergies or significant elevated creatinine/renal failure
9. Uncorrected coagulopathy
10. Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
11. Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
12. Subjects who are uncooperative or cannot follow instructions.
13. Mental state that may preclude completion of the study procedure or obtention of informed consent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
95 Years
Study:
NCT02006303
Study Brief:
Protocol Section:
NCT02006303