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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06607094
Eligibility Criteria:
Inclusion Criteria:
1. Male subjects ≥ 45 years of age who have obstructive symptoms secondary to BPH requiring invasive intervention.
2. IPSS score of ≥ 13.
3. Qmax: Peak flow rate ≤ 15 ml/sec.
4. Post-void residual (PVR) \< 300 ml.
5. Prostate volume \> 30 ml.
6. Subject able to complete the study protocol in the opinion of the Principal Investigator.
Exclusion Criteria:
1. History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
2. Any prior minimally invasive intervention or surgical intervention for the symptoms of BPH.
3. Currently enrolled in another clinical trial.
4. Confirmed or suspected malignancy of prostate or bladder.
5. Documented active urinary tract infection by culture or bacterial prostatitis.
6. Neurogenic bladder or sphincter abnormalities.
7. Urethral strictures, bladder neck contracture or muscle spasms.
8. Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
9. Subjects who are interested in maintaining fertility.
10. Significant urge incontinence.
11. Unable or unwilling to sign the Informed Consent Form.
12. Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT06607094
Study Brief:
Protocol Section:
NCT06607094