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Global Performance Evaluation of the AMS CONTINUUM™ Device

This study has been completed.
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT01083199
First received: March 4, 2010
Last updated: June 6, 2011
Last verified: June 2011

March 4, 2010
June 6, 2011
October 2007
November 2010   (final data collection date for primary outcome measure)
  • Successful Device placement [ Time Frame: During Radical Prostatectomy ] [ Designated as safety issue: No ]
  • Functionally adequate vesico-urethral anastomosis within 21 days post-procedure in subjects with successful Device placement [ Time Frame: 7-21 days post-Device placement ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01083199 on ClinicalTrials.gov Archive Site
  • Intraoperative/Postoperative parameters [ Time Frame: At Device placement ] [ Designated as safety issue: No ]
  • Percentage of subjects demonstrating functionally adequate anastomosis at the 1st and 2nd Device removal visits [ Time Frame: 7 and 14 days post-Device placement ] [ Designated as safety issue: No ]
  • Incontinence rate and I-QOL score [ Time Frame: Baseline, 6-week, 6 and 12-month evaluations ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Global Performance Evaluation of the AMS CONTINUUM™ Device
Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
  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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Device: CONTINUUM™
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Other Name: Anastomosis Device
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Spain
 
NCT01083199
PE0702
No
Rudy Padua, PhD/Clinical Program Manager, American Medical Systems, Inc.
American Medical Systems
Not Provided
Principal Investigator: Evangelos Liatsikos, MD University of Patras
Principal Investigator: Carlos Hernandez, MD Hospital University Gregorio Maranon
American Medical Systems
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP