Performance Evaluation of the AMS CONTINUUM™ Device

NCT00894933 | Completed Results

• 2 other identifiers: PE0814G090011
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

Brief Summary

1. 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. 2.To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Radical Prostatectomy; Vesico-Urethral Anastomosis

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Intraoperative/Postoperative Parameters - Estimated 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

  At Device placement

• Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time

  At Device placement

Study Arms (1)

Continuum

EXPERIMENTAL

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™

Interventions

CONTINUUM™ DEVICE

Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.

Also known as: Anastomosis Device

Continuum

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• American Medical Systems: lead

Study Sites (6)

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

Center for Urology

Rochester, New York, 14619, United States

Location

Urologic Consultants of Southeastern Pennsylvania

Philadelphia, Pennsylvania, 19004, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Urology San Antonio Research PA

San Antonio, Texas, 78205, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Continuity of Patient Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Laura Olson, Clinical Project Manager
• Organization: American Medical Systems

laura.olson2@bsci.com

952-930-6428

Study Officials

• Naveen Kella, MD

  Urology San Antonio Research PA

  PRINCIPAL INVESTIGATOR

• John Libertino, MD

  Lahey Clinic Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 7, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 22, 2018
• Results First Posted: March 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)