Status:
COMPLETED
Performance Evaluation of the AMS CONTINUUM™ Device
Lead Sponsor:
American Medical Systems
Conditions:
Prostate Cancer
Eligibility:
MALE
40+ years
Phase:
NA
Brief Summary
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2. To verify CONTINUUM™ device per...
Detailed Description
Surgery is the main treatment for localized prostate cancer. The most common technique is a "radical prostatectomy," which involves removing the prostate gland, seminal vesicles and nearby lymph nodes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00894933
Start Date
May 1 2009
End Date
December 1 2010
Last Update
February 22 2018
Active Locations (6)
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1
Arkansas Urology
Little Rock, Arkansas, United States, 72211
2
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
3
Center for Urology
Rochester, New York, United States, 14619
4
Urologic Consultants of Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States, 19004