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
  Purpose
  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 Intervention Phase
Prostate Cancer
Device: CONTINUUM™
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: October 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CONTINUUM™
    Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
    Other Name: Anastomosis Device
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083199

Locations
Greece
University of Patras
Rio-Patras, Greece, 26500
Spain
Hospital University Gregorio Maranon
Madrid, Spain, 28007
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Evangelos Liatsikos, MD University of Patras
Principal Investigator: Carlos Hernandez, MD Hospital University Gregorio Maranon
  More Information

No publications provided

Responsible Party: Rudy Padua, PhD/Clinical Program Manager, American Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01083199     History of Changes
Other Study ID Numbers: PE0702
Study First Received: March 4, 2010
Last Updated: June 6, 2011
Health Authority: Greece: Ethics Committee
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by American Medical Systems:
Prostate Cancer
Radical Prostatectomy
Vesico-Urethral Anastomosis

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 21, 2014