Global Performance Evaluation of the AMS CONTINUUM™ Device

American Medical Systems

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer

Treatments

Device: CONTINUUM™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01083199

PE0702

Details and patient eligibility

About

To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure.
To assess clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.

Full 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.

Enrollment

10 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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