Global Performance Evaluation of the AMS CONTINUUM™ Device

Prostate Cancer Clinical Trial

Official title:

Global 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: NCT01083199
• Other study ID #: PE0702
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2010
• Last updated: June 6, 2011
• Start date: October 2007
• Est. completion date: November 2010

Study information

• Verified date: June 2011
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeSpain: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: November 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

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Greece	University of Patras	Rio-Patras
Spain	Hospital University Gregorio Maranon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Countries where clinical trial is conducted

Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Device placement		During Radical Prostatectomy	No
Primary	Functionally adequate vesico-urethral anastomosis within 21 days post-procedure in subjects with successful Device placement		7-21 days post-Device placement	No
Secondary	Intraoperative/Postoperative parameters		At Device placement	No
Secondary	Percentage of subjects demonstrating functionally adequate anastomosis at the 1st and 2nd Device removal visits		7 and 14 days post-Device placement	No
Secondary	Incontinence rate and I-QOL score		Baseline, 6-week, 6 and 12-month evaluations	No
Secondary	Bladder neck contracture (BNC) rate		Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal	No