Clinical trial NCT00894933: Performance Evaluation of the AMS CONTINUUM™ Device
Official title: Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Radical Prostatectomy
Vesico-Urethral Anastomosis
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 33
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety - Infection That Requires IV Antibiotics or Re-hospitalization
timeFrame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
measure: Successful Device Placement
timeFrame: At Device placement
measure: Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement
timeFrame: 7-21 days post-Device placement
measure: Safety - Perforation of the Bowel or Bladder
timeFrame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
measure: Safety - Creation of a False Passage
timeFrame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
measure: Safety - Urinary Retention Requiring Catheterization Post-Device Removal
timeFrame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
measure: Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention
timeFrame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
measure: Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention
timeFrame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
measure: Safety - Bladder Neck Contracture
timeFrame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Secondary outcomes:
measure: Intraoperative/Postoperative Parameters - Estimated Blood Loss
timeFrame: At Device placement
measure: Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts
timeFrame: 7-10 and 13 - 15 days post-Device placement
measure: Intraoperative/Postoperative Parameters - Total Device Placement Time
timeFrame: At Device placement
measure: Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time
timeFrame: At Device placement
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Center for Urology
state: New York
city: Philadelphia
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research PA
state: Texas
Study officials:
affiliation: Urology San Antonio Research PA
name: Naveen Kella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Clinic Medical Center
name: John Libertino, MD
role: PRINCIPAL_INVESTIGATOR
References: