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Global Performance Evaluation of the AMS CONTINUUM™ Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01083199
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Information provided by (Responsible Party):
American Medical Systems

Brief Summary:
  1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure.
  2. To assess clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: CONTINUUM™ Phase 4

Detailed Description:

Radical prostatectomy (RP) is the most utilized surgical treatment option for localized prostate cancer due to the multi-focal nature of the disease. RP is most suitable for otherwise healthy men whose cancer is limited to a small area. The RP procedure involves removing the prostate gland, seminal vesicles and nearby lymph nodes. One of the most technically challenging and critical aspects in all of these surgical approaches is reconstruction of the interrupted urinary tract by hand sewing the vesico-urethral anastomosis. This is where the bladder neck is sewn to the urethra after the prostate has been removed.

CONTINUUM™ (study Device) is to be used as part of the RP procedure by facilitating the approximation of the bladder neck and urethral stump. The Device brings together and holds the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs thereby minimizing extravasation. The Device also provides a conduit for drainage of urine from the bladder out the urethra during tissue healing.

The concept of the CONTINUUM™ device and the feasibility of its operation have been successfully 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 focus of the proposed study is to further verify the performance of the Device in global research centers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
Study Start Date : October 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CONTINUUMTM Device: CONTINUUM™
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Other Name: Anastomosis Device

Primary Outcome Measures :
  1. Successful Device Placement [ Time Frame: During Radical Prostatectomy ]
    Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.

  2. Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement [ Time Frame: 7-21 days post-Device placement ]

    Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window.

    The following defines the timeframe of each removal attempt:

    • 7-day window (7-10 days post-implant)
    • 14-day window (13-15 days post-implant)
    • 21-day window (19-21 days post-implant)

Secondary Outcome Measures :
  1. Intraoperative/Postoperative Parameters [ Time Frame: At Device placement ]
  2. Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits [ Time Frame: 7 and 14 days post-Device placement ]
  3. Incontinence Rate and I-QOL Score [ Time Frame: Baseline, 6-week, 6 and 12-month evaluations ]
  4. Bladder Neck Contracture (BNC) Rate [ Time Frame: Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study

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)
  • A history of:

    1. Recurrent urinary tract infections (UTI)
    2. Recurrent stricture disease
  • 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
  • Allergy to nitinol, nickel, titanium or silicone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01083199

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University of Patras
Rio-Patras, Greece, 26500
Hospital University Gregorio Maranon
Madrid, Spain, 28007
Sponsors and Collaborators
American Medical Systems
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Principal Investigator: Evangelos Liatsikos, MD University of Patras
Principal Investigator: Carlos Hernandez, MD Hospital University Gregorio Maranon
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Responsible Party: American Medical Systems Identifier: NCT01083199    
Other Study ID Numbers: PE0702
First Posted: March 9, 2010    Key Record Dates
Results First Posted: April 12, 2016
Last Update Posted: April 12, 2016
Last Verified: June 2011
Keywords provided by American Medical Systems:
Prostate Cancer
Radical Prostatectomy
Vesico-Urethral Anastomosis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases