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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT03912558
Eligibility Criteria:
Inclusion Criteria:
1. Age 50 or older
2. Verified BPH with prostate size of at least 30 grams or of 25 mm.
3. Signed Informed Consent
4. Failure, intolerance or patient non-compliance of medical treatment
5. Patients suffering from LUTS symptoms of BPH (IPSS \>12, Qmax=\<13 ml/sec)
6. Patient's voided volume of at least 125 ml in uroflow test
7. Patients not eligible for surgery or refusing surgery
Exclusion Criteria:
1. Known sensitivity to Nickel
2. Active Prostatitis
3. Urethral strictures
4. Prior surgery of prostate (simple or radical)
5. Currently active bladder tumor
6. Suspected neurogenic urinary bladder
7. Suspected a-contractile bladder
8. Enlarged median lobe of prostate.
9. Bladder Neck stricture or contracture
10. Urethral pathology: diverticula, strictures, tumors, fistula
11. Clinically Significant urinary tract infection
12. Uncontrolled bleeding disorders
13. Uncontrolled diabetes mellitus
14. Severe medical diseases precluding a minimally invasive procedure
15. Present active urinary stone disease
16. Patients who are under anticoagulants therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Study:
NCT03912558
Study Brief:
Protocol Section:
NCT03912558