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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT05389202
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic benign prostatic hypertrophy (prostate volume \> 50, IPSS \>7, QoL\>2) or patients catheterized after acute retention of urine with failed catheterization.
* Creatinine clearance \> 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
* Adult patients (≥18 years).
* Patients with an indication for prostate embolization.
* Patient with free and informed consent.
* Patient who have signed the consent form.
* Patient affiliated or beneficiary of a health insurance plan.
Exclusion Criteria:
* Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
* Severe renal impairment with renal function \<30mL/min.
* Contraindication to prostate embolization (aorto-iliac bypass)
* Patient participating in research defined as Category 1 Research Involving Human Subjects.
* Patient in an exclusion period as determined by another study.
* Patient under court protection, guardianship or curatorship.
* Patient unable to give consent.
* Patient for whom it is impossible to give informed information.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05389202
Study Brief:
Protocol Section:
NCT05389202