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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT00894933
Eligibility Criteria:
Inclusion Criteria:
* All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study.
* The Subject is willing and able to return for study follow-up visits according to the protocol.
* The Subject can be off diuretics and blood thinners for at least one week prior to surgery.
Exclusion Criteria:
* If contraindicated for surgery
* Inability to understand the study or a history of non-compliance with medical advice
* Unwilling or unable to sign an Informed Consent Form (ICF)
* Participation in another clinical trial
* Previously implanted urological device
* A history of Recurrent urinary tract infections (UTI)
* A history of stricture disease
* Prior invasive prostate treatments (e.g., TURP, TUIP, laser therapy, radiotherapy, cryotherapy)
* Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease)
* Uncontrolled insulin-dependent diabetes
* Chemotherapy within the past 6 months
* Non-topical steroid use within the past 6 months
* History of connective tissue or autoimmune conditions
* Compromised immune system
* Allergy to nitinol, nickel, titanium or silicone
* Body Mass Index greater than or equal to 30
* American Society of Anesthesiologists Score of \> 3
* Prostate size greater than or equal to 50 grams as determined by TRUS
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT00894933
Study Brief:
Protocol Section:
NCT00894933