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Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy


N/A
40 Years
N/A
Not Enrolling
Male
Prostate Cancer

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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 TexasDallas, Texas  75231
Arkansas UrologyLittle Rock, Arkansas  72211
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Center for UrologyRochester, New York  14619
Urologic Consultants of Southeastern PennsylvaniaPhiladelphia, Pennsylvania  19004
Urology San Antonio Research PASan Antonio, Texas  78205