Performance Evaluation of the AMS CONTINUUM™ Device

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894933
• Other study ID #: PE0814
• Secondary ID: G090011
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: January 24, 2018
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2017
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Arkansas Urology	Little Rock	Arkansas
United States	Urologic Consultants of Southeastern Pennsylvania	Philadelphia	Pennsylvania
United States	Center for Urology	Rochester	New York
United States	Urology San Antonio Research PA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Successful Device Placement	Defined as the establishment of a water-tight anastomosis immediately post-Device placement.	At Device placement
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts		7-10 and 13 - 15 days post-Device placement
Secondary	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
Secondary	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