Global Performance Evaluation of the AMS CONTINUUM™ Device

NCT ID: NCT01083199

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONTINUUMTM

Group Type: EXPERIMENTAL

CONTINUUM™

Intervention Type: DEVICE

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

Interventions

CONTINUUM™

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

Intervention Type: DEVICE

Other Intervention Names

Anastomosis Device

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American Medical Systems

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evangelos Liatsikos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Patras

Carlos Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital University Gregorio Maranon

Locations

University of Patras

Rio-Patras, , Greece

Hospital University Gregorio Maranon

Madrid, , Spain

Countries

Greece; Spain

Other Identifiers

PE0702

Identifier Type: -

Identifier Source: org_study_id