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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT03495258
Eligibility Criteria:
Inclusion Criteria:
* Male at least 45 years of age.
* Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
* IPPS symptom score ≥ 12 at screening visit.
* Prostate volume on DRE estimated to be \> 30cc.
* Voluntarily signed informed consent agreement prior to the performance of any study procedures.
Exclusion Criteria:
* Any prior invasive intervention for BPH.
* PSA level greater than 10 ng/ml at screening without either a negative biopsy or documented explanation of why no biopsy was performed.
* Medical condition unfit for surgery
* History or current evidence of carcinoma of the prostate.
* Documented bacterial prostatitis within the past 3 months.
* Known severe bleeding disorder.
* Unable to follow protocol directions or sign informed consent due to organic brain or psychiatric disease.
* History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT03495258
Study Brief:
Protocol Section:
NCT03495258