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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTINUUMTM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONTINUUM™ | Device | Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Device Placement | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative/Postoperative Parameters | At Device placement | |
| Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits | 7 and 14 days post-Device placement |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Evangelos Liatsikos, MD | University of Patras | Principal Investigator |
| Carlos Hernandez, MD | Hospital University Gregorio Maranon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Patras | Rio-Patras | 26500 | Greece | |||
| Hospital University Gregorio Maranon |
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| ID | Title | Description |
|---|---|---|
| FG000 | AMS CONTINUUM™ Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AMS CONTINUUM™ Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Successful Device Placement | Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement. | Posted | Number | participants | During Radical Prostatectomy |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMS CONTINUUM™ Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| False Passage | Renal and urinary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Olson, Clinical Project Manager | American Medical Systems | 952-930-6428 | laura.olson2@bsci.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003266 | Continuity of Patient Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Incontinence Rate and I-QOL Score | Baseline, 6-week, 6 and 12-month evaluations |
| 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 |
| Madrid |
| 28007 |
| Spain |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful 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:
| Posted | Number | participants with device removal by 21d | 7-21 days post-Device placement |
|
|
|
| Secondary | Intraoperative/Postoperative Parameters | Not Posted | At Device placement |
| Secondary | Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits | Not Posted | 7 and 14 days post-Device placement |
| Secondary | Incontinence Rate and I-QOL Score | Not Posted | Baseline, 6-week, 6 and 12-month evaluations |
| Secondary | Bladder Neck Contracture (BNC) Rate | Not Posted | Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal |
| 6 |
| 10 |
| 6 |
| 10 |
| Migration | Renal and urinary disorders |
|
| Separation/Distruption of Anastomosis | Renal and urinary disorders |
|
| Urinary Retention | Renal and urinary disorders |
|
| Urinary Tract Infection (UTI) | Renal and urinary disorders |
|
| Hematuria | Renal and urinary disorders |
|
| Rectal Injury | Renal and urinary disorders |
|
| Separation/Disruption of Anastomosis | Renal and urinary disorders |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |