Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
40 Years
N/A
Male
Prostate Cancer
Trial Information
Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Outcome Time Frame:
At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety Issue:
Yes
Principal Investigator
Naveen Kella, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Urology San Antonio Research PA
Authority:
United States: Food and Drug Administration
Study ID:
PE0814
NCT ID:
NCT00894933
Start Date:
May 2009
Completion Date:
December 2010
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Radical Prostatectomy
- Vesico-Urethral Anastomosis
- Prostatic Neoplasms
Name | Location |
|---|---|
| Urology Clinics of North Texas | Dallas, Texas 75231 |
| Arkansas Urology | Little Rock, Arkansas 72211 |
| Lahey Clinic Medical Center | Burlington, Massachusetts 01805 |
| Center for Urology | Rochester, New York 14619 |
| Urologic Consultants of Southeastern Pennsylvania | Philadelphia, Pennsylvania 19004 |
| Urology San Antonio Research PA | San Antonio, Texas 78205 |
