Performance Evaluation of the AMS CONTINUUM™ Device
- Conditions
- Prostate Cancer
- Interventions
- Device: CONTINUUM™
- Registration Number
- NCT00894933
- Lead Sponsor
- American Medical Systems
- 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 performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.
- 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 33
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Continuum CONTINUUM™ Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.
- Primary Outcome Measures
Name Time Method Safety - Creation of a False Passage At Device placement, Device removal, 4 weeks post-Device removal, 6 months 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.
Safety - Urinary Retention Requiring Catheterization Post-Device Removal At Device placement, Device removal, 4 weeks post-Device removal, 6 months 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.
Safety - Infection That Requires IV Antibiotics or Re-hospitalization At Device placement, Device removal, 4 weeks post-Device removal, 6 months 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.
Successful Device Placement At Device placement Defined as the establishment of a water-tight anastomosis immediately post-Device placement.
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement 7-21 days post-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)
Safety - Perforation of the Bowel or Bladder At Device placement, Device removal, 4 weeks post-Device removal, 6 months 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.
Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention At Device placement, Device removal, 4 weeks post-Device removal, 6 months 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.
Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention At Device placement, Device removal, 4 weeks post-Device removal, 6 months 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.
Safety - Bladder Neck Contracture At Device placement, Device removal, 4 weeks post-Device removal, 6 months 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.
- Secondary Outcome Measures
Name Time Method Intraoperative/Postoperative Parameters - Estimated Blood Loss At Device placement To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts 7-10 and 13 - 15 days post-Device placement Intraoperative/Postoperative Parameters - Total Device Placement Time At Device placement 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.
Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time At Device placement 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.
Trial Locations
- Locations (6)
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
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Urology San Antonio Research PA
🇺🇸San Antonio, Texas, United States