Performance Evaluation of the AMS CONTINUUM™ Device
- To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy.
- To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy|
- Safety [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ] [ Designated as safety issue: Yes ]
- Successful Device placement [ Time Frame: At Device placement ] [ Designated as safety issue: No ]
- Functionally adequate vesico-urethral anastomosis within 21 days post-Device placement in Subjects with successful Device placement [ Time Frame: 7-21 days post-Device placement ] [ Designated as safety issue: No ]
- Intraoperative/Postoperative parameters [ Time Frame: At Device placement ] [ Designated as safety issue: No ]
- Percentage of Subjects demonstrating functionally adequate anastomosis at the 1st and 2nd Device removal visits [ Time Frame: 7 and 14 days post-Device placement ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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. Radical prostatectomy is a major operation, most suitable for otherwise healthy men whose cancer does not appear to have spread.One of the most technically challenging aspects of this surgery is reconstruction of the interrupted urinary tract by hand suturing the bladder neck anastomosis, in which the bladder neck is sewn to the urethra after the prostate has been removed.
CONTINUUM™ (study Device) is a surgical device intended to be used as part of the radical prostatectomy procedure. The Device facilitates approximation of the bladder neck and urethral stump by bringing together and holding the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs. CONTINUUM™ also approximates the bladder and urethral stump to minimize extravasation, while simultaneously providing a conduit for drainage of urine from the bladder while the anastomotic site heals.
The concept of the CONTINUUM™ device and the feasibility of its operation have been tested in animal and human studies. Pilot clinical studies in the United States (G060095) found that the majority of Subjects who received and were discharged with the Device demonstrated a water-tight vesico-urethral anastomosis at the first Device removal visit. Additionally, no unanticipated adverse device effects (UADEs) were reported. The intent of this study is to verify CONTINUUM™ device performance across a variety of US sites and physicians using updated CONTINUUM™ device design modifications and physician training methodology on Device implant and removal techniques prior to initiation of a randomized US Pivotal study.
|United States, Arkansas|
|Little Rock, Arkansas, United States, 72211|
|United States, Massachusetts|
|Lahey Clinic Medical Center|
|Burlington, Massachusetts, United States, 01805|
|United States, New York|
|Center for Urology|
|Rochester, New York, United States, 14619|
|United States, Pennsylvania|
|Urologic Consultants of Southeastern Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19004|
|United States, Texas|
|Urology Clinics of North Texas|
|Dallas, Texas, United States, 75231|
|Urology San Antonio Research PA|
|San Antonio, Texas, United States, 78205|
|Principal Investigator:||Naveen Kella, MD||Urology San Antonio Research PA|
|Principal Investigator:||John Libertino, MD||Lahey Clinic Medical Center|