ПЕРСПЕКТИВНОЕ, МНОГОЦЕНТРОВОЕ, ОДНОРУКОЯЧНОЕ НАБЛЮДАТЕЛЬНОЕ ИССЛЕДОВАНИЕ ПОСЛЕ РЫНКА ДЛЯ ОЦЕНКИ БЕЗОПАСНОСТИ И КЛИНИЧЕСКИХ ХАРАКТЕРИСТИК БИОРАЗЛАГАЕМОГО БИЛИАРНОГО И ПАНКРЕАТИЧЕСКОГО СТЕНТА АРХИМЕД (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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: NIta Gondaliya
- Номер телефона: +49 1716578285
- Электронная почта: ngondaliya@q3medical.com
Учебное резервное копирование контактов
- Имя: Manfred Guelcher
- Номер телефона: +4941716578200
- Электронная почта: mguelcher@q3medical.com
Места учебы
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Düsseldorf, Германия, 40217
- Рекрутинг
- Evangelisches Krankenhaus Düsseldorf
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Контакт:
- Biljana Dimitrijevic, PhD
- Номер телефона: +49 (0)211919483 601
- Электронная почта: Biljana.Dimitrijevic@evk-duesseldorf.de
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Контакт:
- Carina Friesl
- Электронная почта: carina.friesl@evk-duesseldorf.de
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Главный следователь:
- Dr. Thomas Veiser, PhD
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Afula, Израиль, 1834111
- Завершенный
- Emek Medical Center
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Salamanca, Испания, 37007
- Рекрутинг
- Hospital Universitario de Salamanca
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Контакт:
- Solorzano Garcia Ignacio
- Номер телефона: 55400 +34 679441022
- Электронная почта: isolorzano.ibsal@saludcastillayleon.es
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Главный следователь:
- Dr. Alberto Álvarez Delgado, MD, PhD
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Forlì, Италия, 47121
- Завершенный
- AUSL Romagna Ospedale Morgagni - Pierantoni
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Pavia, Италия, 27100
- Активный, не рекрутирующий
- Gastroenterology and Digestive Endoscopy Unit Fondazione I.R.C.C.S. Policlinico San Matteo
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Roma, Италия, 00128
- Активный, не рекрутирующий
- UCBM - Campus Bio-Medico University
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Milano
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Rozzano, Milano, Италия, 20089
- Активный, не рекрутирующий
- Endoscopy Unit, Humanitas Research Hospital
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Singapore, Сингапур, 308433
- Завершенный
- Tan Tock Seng Hospital Pte Ltd,
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Ljubljana, Словения, 1000
- Рекрутинг
- University Medical Center Ljubljana
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Контакт:
- Karin Pulevic, VS
- Номер телефона: +38615228515
- Электронная почта: karin.pulevic@kclj.si
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Контакт:
- Dr. Martina Jaklič, MD
- Номер телефона: +38615222037
- Электронная почта: martina.jaklic@kclj.si
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Главный следователь:
- Dr Samo Plut, MD
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Helsinki, Финляндия, 00290
- Завершенный
- HUS Helsinki University Hospital
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Paris, Франция, 75015
- Активный, не рекрутирующий
- Hôpital Européen Georges-Pompidou HEGP Service d'Hépato-gastro-entérologie et endoscopies digestives
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Patients that will respect the inlcusion criteria will be enrolled in the study.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Primary Safety endpoint
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Secondary endpoints are defined as:
Временное ограничение: 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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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- QM-NI-ABS-034
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .