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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01790451
Eligibility Criteria:
Inclusion Criteria:
1. Patients with prostate cancer who are indicated to undergo a radical prostatectomy
2. Life expectancy of \> 10 years
3. Able to visualize prostate gland adequately on transrectal US imaging during enrolment evaluation
4. No prostate calcification greater than 5 mm
5. Ability of subject to stop anticoagulant and anti-platelet therapy for 7 days prior and 7 days post procedure
Exclusion Criteria:
1. Other Conditions/Status
1. Bleeding disorder as determined by prothrombin time (PT) \> 14.5 seconds, partial thromboplastin time (PTT) \> 34 seconds, and Platelet Count \< 140/microliter (uL)
2. Active urinary tract infection (UTI)
3. History of bladder neck contracture
4. Anaesthesia Surgical Assignment, category IV or greater
5. History of inflammatory bowel disease
6. Concurrent major debilitating illness
7. Prior or concurrent malignancy
8. Cardiac History
9. Implantable cardioverter-defibrillator (ICD) / Pacemaker
2. Prior or current therapies
1. Biologic therapy for prostate cancer
2. Chemotherapy for prostate cancer
3. Hormonal therapy for prostate cancer within 3 months of procedure
4. Radiotherapy for prostate cancer
5. Transurethral prostatectomy (TURP), urethral stent
6. Prior major rectal surgery (except haemorrhoids)
7. Inability or unwillingness to tolerate temporary cessation of concurrent anticoagulation therapy or anti-platelet drugs for a period of 7days prior to procedure and up to 7 days after procedure
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01790451
Study Brief:
Protocol Section:
NCT01790451