"1"^^ . . "0"^^ . . "Stent / Stent Degradabiln\u00ED / Degradable Kryt\u00FD / Covered Dehiscence / Dehiscence P\u00ED\u0161t\u011Bl / Fistula Tlust\u00E9 st\u0159evo / Colon Kone\u010Dn\u00EDk / Rectum"@en . "2011-03-31+02:00"^^ . "0"^^ . "2010-11-30+01:00"^^ . "0"^^ . . "The submitted project is an integral part of the development of degradable enteral stent. This stent is a medical implantable device which belongs to Class III (according to Annex IX of Council Directive 93/42/EEC, concerning medical devices, as amended) and it is necessary to perform, i.a. preclinical evaluation before placing on the market. The experimental laboratory of the Faculty of Military Health Sciences is asked to perform preclinical evaluation in vivo (the experiment on animals). Pig is selected as an experimental animal for this project. The aim of the study is to monitor and document the degradation process of enteral degradable stent in experimental animals (i.e. reaction of mucosa to implanted stent; degradation process of stent and covering, eventually; healing process of mucosa after stent degradation). Development of degradable covered stent would make possible endoscopic management of conditions (benign lesions of colorectum - fistulas, dehiscences; particularly) in which covering of the stent plays crucial role, i.e. seals leakage from the bowel to other anatomic structures and subsequent degradation of medical device eliminates necessity of its extraction after healing. The equipment complex (housing of animals and utility premises, operating theaters), apparatuses (X-ray apparatus, endoscopes) and skilled employees will be exploited during the experimentation. The project is planned since October 2010 till March 2011. The experimental animals will be bought and after a period of acclimatization the implantation of the stent will be performed. The shortest implantation period is planned for 2 weeks, the longest one for 18 weeks. The animal will be euthanized according to the plan, the autopsy will be performed and the samples of the tissue and stent for microscopic evaluation will be collected."@en . . . "http://www.isvav.cz/projectDetail.do?rowId=UBRIF201009"^^ . "0"^^ . . . . "UBRIF201009" . . . "Preclinical in vivo evaluation of enteral degradable stent"@en . . . . . . . "Preklinick\u00E9 hodnocen\u00ED enter\u00E1ln\u00EDho degradabiln\u00EDho stentu" . "2010-10-01+02:00"^^ . "P\u0159edkl\u00E1dan\u00FD projekt je sou\u010D\u00E1st\u00ED v\u00FDvoje degradabiln\u00EDho enter\u00E1ln\u00EDho stentu. Jedn\u00E1 se o zdravotnick\u00FD prost\u0159edek - implant\u00E1t - t\u0159\u00EDdy III (podle P\u0159\u00EDlohy IX, Sm\u011Brnice Rady Evropy 93/42/EHS, o zdravotnick\u00FDch prost\u0159edc\u00EDch, v platn\u00E9m zn\u011Bn\u00ED), a proto je nutn\u00E9 p\u0159ed jeho uveden\u00EDm na trh zajistit mj. testov\u00E1n\u00ED in vivo (experiment na zv\u00ED\u0159atech). Pokusn\u00FDm zv\u00ED\u0159etem je pro projekt zvoleno prase. C\u00EDlem studie je sledov\u00E1n\u00ED a dokumentov\u00E1n\u00ED procesu degradace enter\u00E1ln\u00EDho degradabiln\u00EDho stentu u pokusn\u00FDch zv\u00ED\u0159at (tj. reakce sliznice na implantovan\u00FD stent, proces degradace stentu a pop\u0159. krytu, proces hojen\u00ED sliznice po degradaci stentu). Vyvinut\u00ED degradabiln\u00EDho stentu opat\u0159en\u00E9ho potahem by umo\u017Enilo endoskopick\u00E9 \u0159e\u0161en\u00ED stav\u016F (benign\u00ED posti\u017Een\u00ED zejm\u00E9na kolorekta - p\u00ED\u0161t\u011Ble, dehiscence), kde potah pln\u00ED kl\u00ED\u010Dovou funkci, tj. ut\u011Bs\u0148uje komunikaci mezi st\u0159evem a jin\u00FDmi anatomick\u00FDmi strukturami) a n\u00E1sledn\u00E1 degradace zdravotnick\u00E9ho prost\u0159edku eliminuje nutnost jeho extrakce po zhojen\u00ED. P\u0159i \u0159e\u0161en\u00ED pokusu bude vyu\u017Eito technologick\u00E9 z\u00E1zem\u00ED (prostory pro ust\u00E1jen\u00ED zv\u00ED\u0159at a manipulaci s nimi, opera\u010Dn\u00ED s\u00E1ly), za\u0159\u00EDzen\u00ED (rentgen, endoskopy) a odborn\u00E9 z\u00E1zem\u00ED FVZ. Proveden\u00ED projektu je pl\u00E1nov\u00E1no na obdob\u00ED \u0159\u00EDjen 2010 a\u017E b\u0159ezen 2011. V pr\u016Fb\u011Bhu \u0159\u00EDjna budou nakoupena pokusn\u00E1 zv\u00ED\u0159ata a po aklimatizaci bude provedena implantace stentu. Nejkrat\u0161\u00ED implanta\u010Dn\u00ED obdob\u00ED je pl\u00E1nov\u00E1no na 2 t\u00FDdny a nejdel\u0161\u00ED na 18 t\u00FDdn\u016F. Zv\u00ED\u0159ata budou na konci pokusu podle pl\u00E1nu utr\u00E1cena, bude provedena pitva a odebr\u00E1ny vzorky na mikroskopick\u00E9 vy\u0161et\u0159en\u00ED tk\u00E1n\u011B a stentu." . "2013-05-06+02:00"^^ . .