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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00937833
Eligibility Criteria:
Inclusion Criteria:
* Patients must have organ confined prostate cancer.
* Patients must have PSA\< 15.
* Patients must have clinical stage prostate cancer \< cT3.
* Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
* Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
* Patients must be at least 18 years of age.
Exclusion Criteria:
* Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
* Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
* Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
* Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
* Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
* Patients must not have a prior history of radiation to the pelvis.
* Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.
* Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00937833
Study Brief:
Protocol Section:
NCT00937833