Performance Evaluation of the AMS CONTINUUM™ Device

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: CONTINUUM™

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center
  • New York
    • Rochester, New York, United States, 14619
      • Center for Urology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19004
      • Urologic Consultants of Southeastern Pennsylvania
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas
    • San Antonio, Texas, United States, 78205
      • Urology San Antonio Research PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Anastomosis Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Infection That Requires IV Antibiotics or Re-hospitalization	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.	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Successful Device Placement	Defined as the establishment of a water-tight anastomosis immediately post-Device placement.	At Device placement
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful 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)	7-21 days post-Device placement
Safety - Perforation of the Bowel or Bladder	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.	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Creation of a False Passage	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.	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Urinary Retention Requiring Catheterization 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.	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention	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.	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention	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.	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal
Safety - Bladder Neck Contracture	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.	At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative/Postoperative Parameters - Estimated Blood Loss	To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.	At Device placement
Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts		7-10 and 13 - 15 days post-Device placement
Intraoperative/Postoperative Parameters - Total Device Placement Time	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.	At Device placement
Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time	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.	At Device placement

Collaborators and Investigators

• Sponsor: American Medical Systems
• Investigators: Principal Investigator: Naveen Kella, MD, Urology San Antonio Research PA; Principal Investigator: John Libertino, MD, Lahey Clinic Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (Estimate): May 7, 2009

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Prostate Cancer; Radical Prostatectomy; Vesico-Urethral Anastomosis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PE0814; G090011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO