Global Performance Evaluation of the AMS CONTINUUM™ Device

Phase 4

Completed

Conditions: Prostate Cancer

Interventions: Device: CONTINUUM™

Registration Number: NCT01083199

Lead Sponsor: American Medical Systems

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 10

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CONTINUUMTM	CONTINUUM™	-

Primary Outcome Measures

Name	Time	Method
Successful Device Placement	During Radical Prostatectomy	Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement	7-21 days post-Device placement	Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window. The following defines the timeframe of each removal attempt: * 7-day window (7-10 days post-implant) * 14-day window (13-15 days post-implant) * 21-day window (19-21 days post-implant)

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits	7 and 14 days post-Device placement
Incontinence Rate and I-QOL Score	Baseline, 6-week, 6 and 12-month evaluations
Intraoperative/Postoperative Parameters	At Device placement
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