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 performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Arkansas Urology
Little Rock, Arkansas, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Center for Urology
Rochester, New York, United States
Urologic Consultants of Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States
Safety - Infection That Requires IV Antibiotics or Re-hospitalization
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Successful Device Placement
Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
Time frame: At Device placement
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement
Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)
Time frame: 7-21 days post-Device placement
Safety - Perforation of the Bowel or Bladder
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Creation of a False Passage
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Urinary Retention Requiring Catheterization Post-Device Removal
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
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Urology Clinics of North Texas
Dallas, Texas, United States
Urology San Antonio Research PA
San Antonio, Texas, United States
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Bladder Neck Contracture
Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.
Time frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Intraoperative/Postoperative Parameters - Estimated Blood Loss
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.
Time frame: At Device placement
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts
Time frame: 7-10 and 13 - 15 days post-Device placement
Intraoperative/Postoperative Parameters - Total Device Placement Time
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.
Time frame: At Device placement
Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time
To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.
Time frame: At Device placement