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Performance Evaluation of the AMS CONTINUUM™ Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00894933
First received: May 5, 2009
Last updated: January 22, 2017
Last verified: January 2017
  Purpose
  1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy.
  2. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.

Condition Intervention
Prostate Cancer
Device: CONTINUUM™

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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:
  • Safety - Infection That Requires IV Antibiotics or Re-hospitalization [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ]
    Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

  • Successful Device Placement [ Time Frame: At Device placement ]
    Defined as the establishment of a water-tight anastomosis immediately post-Device placement.

  • Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement [ Time Frame: 7-21 days post-Device placement ]
    Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)

  • Safety - Perforation of the Bowel or Bladder [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ]
    Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

  • Safety - Creation of a False Passage [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ]
    Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

  • Safety - Urinary Retention Requiring Catheterization Post-Device Removal [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ]
    Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

  • Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ]
    Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

  • Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ]
    Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.

  • Safety - Bladder Neck Contracture [ Time Frame: At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal ]
    Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.


Secondary Outcome Measures:
  • Intraoperative/Postoperative Parameters - Estimated Blood Loss [ Time Frame: At Device placement ]
    To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.

  • Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts [ Time Frame: 7-10 and 13 - 15 days post-Device placement ]
  • Intraoperative/Postoperative Parameters - Total Device Placement Time [ Time Frame: At Device placement ]
    To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.

  • Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time [ Time Frame: At Device placement ]
    To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.


Enrollment: 33
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuum
Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.
Device: CONTINUUM™
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Other Name: Anastomosis Device

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894933

Locations
United States, Arkansas
Arkansas Urology
Little Rock, Arkansas, United States, 72211
United States, Massachusetts
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, New York
Center for Urology
Rochester, New York, United States, 14619
United States, Pennsylvania
Urologic Consultants of Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States, 19004
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Urology San Antonio Research PA
San Antonio, Texas, United States, 78205
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Naveen Kella, MD Urology San Antonio Research PA
Principal Investigator: John Libertino, MD Lahey Clinic Medical Center
  More Information

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00894933     History of Changes
Other Study ID Numbers: PE0814
G090011
Study First Received: May 5, 2009
Results First Received: January 22, 2017
Last Updated: January 22, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Publications using the data generated from this clinical study are not planned.

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 24, 2017