UN ESTUDIO OBSERVACIONAL PROSPECTIVO, MULTICÉNTRICO, DE UN SOLO BRAZO, POST-COMERCIALIZACIÓN PARA EVALUAR LA SEGURIDAD Y EL RENDIMIENTO CLÍNICO DEL STENT BILIAR Y PANCREÁTICO BIODEGRADABLE ARCHIDES (Registry)
Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium. Stents are typically made from polymeric materials including Polylactic Acid (PLA), Polyglycolide (PGA), Polydioxanone (PDO), Polyethyleneglycol (PEG), Polycaprolactone (PCL), etc., which have been cleared or approved by the FDA and CE-marked as drug carriers, sutures, and bone fixatives. The material is degraded by hydrolysis in, e.g., lactic acid, which is removed from the body by normal metabolic pathways. In the field of gastroenterology, these stents were first introduced in patients with an esophageal stenosis with encouraging results, although esophageal hyperplasia was a frequently encountered complication.
For biliary applications, biodegradable stents have been evaluated in several in-vitro and animal studies that demonstrated that the stents were safe and well tolerated. These stents provided an adequate radial force and resulted in complete stricture resolution within several months. The stents did not show any signs of biliary hyperplasia or integration in the epithelium. Moreover, they seem to have a self-clearing effect on attached biofilm as the outer layer sloughs during the degradation process similarly to the exfoliation of human skin. Also, the stent could be removed from the bile duct, thus offering the possibility of extraction if necessary at various times after implantation.
In 2010, Petryl was the first to use a biodegradable stent in the human bile duct. A stent was successfully placed using percutaneous transhepatic cholangiograpy in two patients with a postsurgical intrahepatic biliary stricture. Transient cholangitis was the only complication encountered and during the two years of follow-up, the bile duct remained patent.
Later, Mauri et al. presented in 2013 and 2016 results of a 107 patient study on a polydioxanone biodegradable biliary stent. The results have been published in the Journal of the European Society of Radiology. The authors concluded that percutaneous placement of a biodegradable biliary stent is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period.
Prior to this study, the ARCHIMEDES device was assessed in the ARCHIMEDES Investigational study which has completed enrolment with 53 patients included, and the results are not yet published. In this study approximately half the stents were deployed in the bile duct (53%) and half in the pancreatic duct. All 53 patients have either completed, exited, or no longer have the study device. No patient remains in the study with a stent in place during the time of the last patient follow-ups. The study concluded without any device-related SAE. Bilirubin was reduced by 25.6%, which exceeded the >20% clinical success criterion, quality of life score improved from 3.7 to 7.9, procedural success was rated 1.4 (good to excellent), and technical success was achieved in all 53 patients.
Data from the ARCHIMEDES Investigational study was used for CE Mark approval, which was obtained in June 2018.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: NIta Gondaliya
- Número de teléfono: +49 1716578285
- Correo electrónico: ngondaliya@q3medical.com
Copia de seguridad de contactos de estudio
- Nombre: Manfred Guelcher
- Número de teléfono: +4941716578200
- Correo electrónico: mguelcher@q3medical.com
Ubicaciones de estudio
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Düsseldorf, Alemania, 40217
- Reclutamiento
- Evangelisches Krankenhaus Düsseldorf
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Contacto:
- Biljana Dimitrijevic, PhD
- Número de teléfono: +49 (0)211919483 601
- Correo electrónico: Biljana.Dimitrijevic@evk-duesseldorf.de
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Contacto:
- Carina Friesl
- Correo electrónico: carina.friesl@evk-duesseldorf.de
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Investigador principal:
- Dr. Thomas Veiser, PhD
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Ljubljana, Eslovenia, 1000
- Reclutamiento
- University Medical Center Ljubljana
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Contacto:
- Karin Pulevic, VS
- Número de teléfono: +38615228515
- Correo electrónico: karin.pulevic@kclj.si
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Contacto:
- Dr. Martina Jaklič, MD
- Número de teléfono: +38615222037
- Correo electrónico: martina.jaklic@kclj.si
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Investigador principal:
- Dr Samo Plut, MD
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Salamanca, España, 37007
- Reclutamiento
- Hospital Universitario de Salamanca
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Contacto:
- Solorzano Garcia Ignacio
- Número de teléfono: 55400 +34 679441022
- Correo electrónico: isolorzano.ibsal@saludcastillayleon.es
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Investigador principal:
- Dr. Alberto Álvarez Delgado, MD, PhD
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Helsinki, Finlandia, 00290
- Terminado
- HUS Helsinki University Hospital
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Paris, Francia, 75015
- Activo, no reclutando
- Hôpital Européen Georges-Pompidou HEGP Service d'Hépato-gastro-entérologie et endoscopies digestives
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Afula, Israel, 1834111
- Terminado
- Emek Medical Center
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Forlì, Italia, 47121
- Terminado
- AUSL Romagna Ospedale Morgagni - Pierantoni
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Pavia, Italia, 27100
- Activo, no reclutando
- Gastroenterology and Digestive Endoscopy Unit Fondazione I.R.C.C.S. Policlinico San Matteo
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Roma, Italia, 00128
- Activo, no reclutando
- UCBM - Campus Bio-Medico University
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Milano
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Rozzano, Milano, Italia, 20089
- Activo, no reclutando
- Endoscopy Unit, Humanitas Research Hospital
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Singapore, Singapur, 308433
- Terminado
- Tan Tock Seng Hospital Pte Ltd,
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients that will respect the inlcusion criteria will be enrolled in the study.
Descripción
Inclusion Criteria:
- Patient eligible for implantation of a pancreatic or billiary stent prior to participate in the study and according to current guidelines
- Patient has provided a signed and dated informed consent (according to the laws and regualtions of the country in which the observational study is conducted)
Exclusion Criteria:
- Age < 18 y
- Inability to understand the purpose of the study or refusal to cooperate
- Not available for routine follow-up visits
- Pregnancy
- Currently participating in a confounding trial before reaching first endpoint.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
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Patients will treated with ARCHIMEDES Biodegradable Biliary and Pancreatic Stent in routine practice
Participants receiving commercially available ARCHIMEDES Biodegradable Biliary and Pancreatic as part of standard care. Safety outcomes are collected for post-marketing surveillance |
Patients will treated with ARCHIMEDES Biodegradable Biliary and Pancreatic Stent in routine clinical practice |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Primary Safety endpoint
Periodo de tiempo: From enrollment to the end of treatment, as per the standard of care.
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Proportion of subjects experiencing procedure- or device-related complications within 30 days including Post-ERCP pancreatitis, Bleeding, Perforation (biliary/pancreatic/duodenal), Stent misplacement, Stent migration, Biliary occlusion, Cholangitis, Severe pain, All-cause death Within 30 days of the index procedure |
From enrollment to the end of treatment, as per the standard of care.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Secondary endpoints are defined as:
Periodo de tiempo: Technical and Procedural success on the Procedure day and clinical success as per the Standard of Care
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Clinical success: patency rate as defined by the rate of freedom of stent replacements at follow-up time points defined by investigators definition of SOC (standard of care) or until planned bridge surgery (defined as no need of stent replacement). Technical success: Accurate stent deployment across the target stricture as evaluated by fluoroscopy and endoscopy. Procedural success will be quantified (using a dedicated score system, Excellence=1, Good=2, Fair=3, Poor=4) by the endoscopist post procedure using the following components:
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Technical and Procedural success on the Procedure day and clinical success as per the Standard of Care
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- QM-NI-ABS-034
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .