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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CONTINUUMTM
|
Rendimiento de CONTINUUM™ para facilitar la anastomosis vesicouretral después de una prostatectomía radical.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Successful Device Placement
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Intraoperative/Postoperative Parameters
Periodo de tiempo: At Device placement
|
At Device placement
|
|
Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits
Periodo de tiempo: 7 and 14 days post-Device placement
|
7 and 14 days post-Device placement
|
|
Incontinence Rate and I-QOL Score
Periodo de tiempo: Baseline, 6-week, 6 and 12-month evaluations
|
Baseline, 6-week, 6 and 12-month evaluations
|
|
Bladder Neck Contracture (BNC) Rate
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Evangelos Liatsikos, MD, University of Patras
- Investigador principal: Carlos Hernandez, MD, Hospital University Gregorio Maranon
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PE0702
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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