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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT00956904
Eligibility Criteria:
Inclusion Criteria:
* Patients must be scheduled for a robotic LRP
* Patients must be between the ages of 35 and 75
* Patients must not have one of the listed exclusion criteria
* Patients must be able to understand and willing to adhere to the study protocol
* Patients must have a clinical stage diagnosis of T1 or T2
* Patients must have a preoperative serum PSA \< 20ng/ml
* Patients must have a biopsy Gleason score of 5-8
Exclusion Criteria:
* Patients less than 35 years of age and over 75 years of age.
* Patients with previous rectal surgery
* Patients with anal stenosis that prevents the TRUS probe insertion
* Patients with extensive abdominal surgery
* Patients with inadequate bowel prep
* Patients who are unwilling or unable to sign informed consent
* Patients on anticoagulation medication (eg. coumadin, lovenox, or heparin)
* Patients with a clinical stage diagnosis of T3 - Patients with a preoperative serum PSA ≥ 20 ng/mL
* Patients with a biopsy Gleason score \< 5 or \> 8
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00956904
Study Brief:
Protocol Section:
NCT00956904