- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01083199
Global Performance Evaluation of the AMS CONTINUUM™ Device
Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy
- 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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Recurrent urinary tract infections (UTI)
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CONTINUUMTM
|
Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful Device Placement
Time Frame: During Radical Prostatectomy
|
Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.
|
During Radical Prostatectomy
|
Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement
Time Frame: 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:
|
7-21 days post-Device placement
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraoperative/Postoperative Parameters
Time Frame: At Device placement
|
At Device placement
|
Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits
Time Frame: 7 and 14 days post-Device placement
|
7 and 14 days post-Device placement
|
Incontinence Rate and I-QOL Score
Time Frame: Baseline, 6-week, 6 and 12-month evaluations
|
Baseline, 6-week, 6 and 12-month evaluations
|
Bladder Neck Contracture (BNC) Rate
Time Frame: Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal
|
Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Evangelos Liatsikos, MD, University of Patras
- Principal Investigator: Carlos Hernandez, MD, Hospital University Gregorio Maranon
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PE0702
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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