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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CONTINUUMTM
|
Performance de CONTINUUM™ pour faciliter l'anastomose vésico-urétrale après prostatectomie radicale.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Successful Device Placement
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Intraoperative/Postoperative Parameters
Délai: At Device placement
|
At Device placement
|
|
Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits
Délai: 7 and 14 days post-Device placement
|
7 and 14 days post-Device placement
|
|
Incontinence Rate and I-QOL Score
Délai: Baseline, 6-week, 6 and 12-month evaluations
|
Baseline, 6-week, 6 and 12-month evaluations
|
|
Bladder Neck Contracture (BNC) Rate
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Evangelos Liatsikos, MD, University of Patras
- Chercheur principal: Carlos Hernandez, MD, Hospital University Gregorio Maranon
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PE0702
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