{"status":"OK","data":{"advertisement":{"id":227282,"title":"\u201cPrzeprowadzenie pilota\u017cowego badania klinicznego wyrobu medycznego - urz\u0105dzenia ABD do celowanej hemodializy pacjent\u00f3w z przewlek\u0142\u0105 chorob\u0105 nerek\u201d//\n\u201cConducting a pilot clinical trial of a medical device - an ABD device for targeted hemodialysis of patients with chronic kidney disease.\u201d","partial_offer_allowed":false,"publication_date":"2023-09-14","submission_deadline":"2023-10-16 23:59:59","planned_sign_date":"2024-10-01","supplementary_orders":null,"terms_of_contract_change":null,"created_at":"2023-09-14 16:15:36","modified_at":"2023-10-17 00:00:03","contact_persons":[{"id":58803,"forename":"Dorota","surname":"Trznadel","phone_number":"","email":"k.miernik@dotomedical.com","created_by":null,"created_at":"2023-09-14 15:58:10","modified_at":"2023-09-14 15:58:10","modified_by":null}],"orders":[{"id":371735,"estimated_value":null,"order_items":[{"id":420147,"description":"Przedmiotem zam\u00f3wienia jest us\u0142uga polegaj\u0105ca na przeprowadzeniu badania klinicznego wyrobu medycznego - urz\u0105dzenia ABD do celowanej hemodializy pacjent\u00f3w ze schy\u0142kow\u0105 niewydolno\u015bci\u0105 nerek. Planowane badanie b\u0119dzie badaniem pilota\u017cowym typu \u2018first-time-in human\u2019 (FTIH), kt\u00f3re b\u0119dzie mia\u0142o na celu potwierdzenie wykonalno\u015bci oraz bezpiecze\u0144stwa/tolerancji zabiegu celowanej hemodializy z urz\u0105dzeniem ABD oraz skuteczno\u015bci usuwania cel\u00f3w molekularnych (bia\u0142ek prozapalnych) z krwi pacjent\u00f3w przez urz\u0105dzenie ABD. Cele molekularne zostan\u0105 ujawnione oferentom po podpisaniu umowy o poufno\u015bci.\nBadanie pilota\u017cowe b\u0119dzie badaniem otwartym, interwencyjnym i zostanie przeprowadzone na pacjentach, kt\u00f3rzy s\u0105 poddawani hemodializie od co najmniej roku, i b\u0119dzie obejmowa\u0142o pojedyncz\u0105 sesj\u0119 hemodializy z pod\u0142\u0105czonym urz\u0105dzeniem ABD. Poni\u017cej przedstawiono wst\u0119pny protok\u00f3\u0142 badania. Protok\u00f3\u0142 ko\u0144cowy, w tym kryteria w\u0142\u0105czenia i wy\u0142\u0105czenia uczestnik\u00f3w badania, zostanie opracowany we wsp\u00f3\u0142pracy z Podwykonawc\u0105/Oferentem na podstawie wynik\u00f3w bada\u0144 przedklinicznych uzyskanych w toku projektu badawczo-rozwojowego.//\nThe subject of the order is a service consisting in conducting a clinical trial of a medical device - an ABD device for targeted hemodialysis of patients with end-stage renal disease. The planned study will be a 'first-time-in human' (FTIH) pilot study, which will aim to confirm the feasibility and safety/tolerability of targeted hemodialysis with an ABD device and the effectiveness of removing molecular targets (pro-inflammatory proteins) from patients' blood by the ABD device . The molecular targets will be disclosed to Bidders after signing a confidentiality agreement.\n\nThe pilot study will be an open-label, interventional study and will be conducted in patients who have been on hemodialysis for at least one year and will include a single hemodialysis session with an attached ABD device. The preliminary study protocol is presented below. The final protocol, including the inclusion and exclusion criteria of study participants, will be developed in cooperation with the Subcontractor/Bidder based on the results of preclinical studies obtained during the research and development project.","warranty_period":null,"cpv_items":[{"id":8513,"code":"73100000-3","name":"Us\u0142ugi badawcze i eksperymentalno-rozwojowe"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":"dolno\u015bl\u0105skie","poviat":"Wroc\u0142aw","commune":"Wroc\u0142aw-Fabryczna","locality":"Wroc\u0142aw","created_by":null,"created_at":"2023-09-14 16:15:36","modified_at":"2023-09-14 16:15:36","modified_by":null,"id":471678,"type":{"id":1,"name":"adres"},"group_uuid":"2eee2911-1565-4420-a161-08c99b6b8ef9"}],"participation_conditions":[{"id":1146954,"description":"Z post\u0119powania o udzielenie zam\u00f3wienia wykluczeniu podlegaj\u0105 Oferenci, kt\u00f3rzy s\u0105 powi\u0105zani osobowo lub kapita\u0142owo z Zamawiaj\u0105cym. Przez powi\u0105zania kapita\u0142owe lub osobowe rozumie si\u0119 wzajemne powi\u0105zania mi\u0119dzy Zamawiaj\u0105cym lub osobami upowa\u017cnionymi do zaci\u0105gania zobowi\u0105za\u0144 w imieniu Zamawiaj\u0105cego lub osobami wykonuj\u0105cymi w imieniu Zamawiaj\u0105cego czynno\u015bci zwi\u0105zane z przygotowaniem i przeprowadzeniem procedury wyboru Wykonawcy a Oferentem, polegaj\u0105ce w szczeg\u00f3lno\u015bci na: \na)\tuczestniczeniu w sp\u00f3\u0142ce jako wsp\u00f3lnik sp\u00f3\u0142ki cywilnej lub sp\u00f3\u0142ki osobowej,\nb)\tposiadaniu co najmniej 10% udzia\u0142\u00f3w lub akcji,\nc)\tpe\u0142nieniu funkcji cz\u0142onka organu nadzorczego lub zarz\u0105dzaj\u0105cego, prokurenta, pe\u0142nomocnika,\nd)\tpozostawaniu w zwi\u0105zku ma\u0142\u017ce\u0144skim, w stosunku pokrewie\u0144stwa lub powinowactwa\nw linii prostej, pokrewie\u0144stwa drugiego stopnia lub powinowactwa drugiego stopnia\nw linii bocznej lub w stosunku przysposobienia, opieki lub kurateli.","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2023-09-14 16:15:36","modified_at":"2023-09-14 16:15:36","modified_by":null,"group_uuid":"c9424b06-e120-43bd-97ba-7368b659e9e4"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2023-09-14 16:15:36","modified_at":"2023-09-14 16:15:36","modified_by":null,"group_uuid":"137c2a1d-6711-49f9-a81c-e7a088b39ff1"}],"evaluation_criteria":[{"id":639934,"price_criterion":true,"description":"Ilo\u015b\u0107 punkt\u00f3w za kryterium cena w/g poni\u017cszego wzoru (licz\u0105c do dw\u00f3ch miejsc po przecinku):\n\n                             Ilo\u015b\u0107 punkt\u00f3w= (C min / C oferty) * 100 pkt\nGdzie:\nC min - najni\u017csza cena ze wszystkich z\u0142o\u017conych ofert \nC oferty  - cena badanej oferty","created_by":null,"created_at":"2023-09-14 16:15:36","modified_at":"2023-09-14 16:15:36","modified_by":null,"group_uuid":"a274865b-848a-4b3c-853b-aedd8feca0c7"}],"is_variant":false,"title":"Pilota\u017cowe bad. kliniczne wyrobu medycznego - urz\u0105dzenia ABD","order_node":{"id":282468},"created_by":null,"created_at":"2023-09-14 16:15:36","modified_at":"2023-09-14 16:15:36","modified_by":null}],"created_by":{"modified_by":null,"id":58475,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"Doto Medical Sp. z o.o.","identification_number_type":"nip","identification_number":"8943200107","address":{"country":"Polska","voivodeship":"dolno\u015bl\u0105skie","poviat":"Wroc\u0142aw","commune":"Wroc\u0142aw-Fabryczna","locality":"Wroc\u0142aw","created_by":null,"created_at":null,"modified_at":null,"modified_by":null,"id":597444,"street":"Legnicka","number_description":"48E","postcode":"54-202"},"created_by":{"modified_by":null,"id":58475,"contact_persons":[]},"created_at":"2023-09-14 16:15:36","modified_at":"2023-09-14 16:15:36","modified_by":{"modified_by":null,"id":58475,"contact_persons":[]},"id":227779},"advertisement":{"id":173151,"number":"2023-58475-173151","publication_date":"2023-09-14","created_by":{"modified_by":null,"id":58475,"contact_persons":[]},"created_at":"2023-09-14 16:15:36","modified_at":"2023-10-17 00:00:03","modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":6,"label":"RESOLVED","name":"Rozstrzygni\u0119te"},"all_available_version_ids":[227282],"enrollment":{"id":41096,"name":"-","number":"002/23","activity":{"created_by":null,"created_at":"2023-02-01 09:22:25","modified_at":"2023-02-01 09:22:25","modified_by":null},"region":null,"institution":{"created_by":null,"created_at":"2023-02-01 09:28:01","modified_at":"2023-02-01 09:28:01","modified_by":null},"full_number":"FENG.01.01-IP.02-002/23","perspective":{},"programme":{"created_by":null,"created_at":"2023-02-01 09:21:41","modified_at":"2023-02-01 09:21:41","modified_by":null},"priority":{"created_by":null,"created_at":"2023-02-01 09:21:51","modified_at":"2023-02-01 09:21:51","modified_by":null},"type":"enrollment","created_by":null,"created_at":"2023-09-13 15:48:17","modified_at":"2023-09-13 15:48:17","modified_by":null},"projects":[],"is_author":false,"is_admin":false},"attachments":[{"origin":{"id":227282,"publication_date":"2023-09-14"},"id":1131558,"name":"DOTO/103/2023/04-Zapytanie ofertowe wraz z Za\u0142.1 i Za\u0142.2","file":{"id":1261158,"name":"DOTO_103_2023_04-Zapytanie ofertowe, Za\u0142.1 i Za\u0142.2.pdf","created_at":"2023-09-14 16:07:22","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1261158"},"group_uuid":"62f90c1b-eb5d-477f-8eac-bad6cee015f6"},{"origin":{"id":227282,"publication_date":"2023-09-14"},"id":1131559,"name":"DOTO/103/2023/04-Za\u0142.1- formularz oferty, Za\u0142. 2- Deklaracja Oferenta edytowalne","file":{"id":1261162,"name":"DOTO_103_2023_04-Za\u0142.1, Za\u0142. 2- edytowalne.docx","created_at":"2023-09-14 16:08:00","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1261162"},"group_uuid":"9e5e4472-3899-4a21-b201-80e05be73d49"},{"origin":{"id":227282,"publication_date":"2023-09-14"},"id":1131560,"name":"DOTO/103/2023/04-Req. of tender and Att.1, Att.2","file":{"id":1261169,"name":"DOTO_103_2023_04-Req. of tender, Att.1, Att.2.pdf","created_at":"2023-09-14 16:09:08","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1261169"},"group_uuid":"cdb81a9e-56e0-4acc-af9a-b853cd64fdde"},{"origin":{"id":227282,"publication_date":"2023-09-14"},"id":1131561,"name":"DOTO/103/2023/04- Att.- Form of Offer 1, Att. 2- Bidder's Declaration editable","file":{"id":1261170,"name":"DOTO_103_2023_04- Att. 1, Att. 2, editable.docx","created_at":"2023-09-14 16:10:34","created_by":{"forename":"Karolina","surname":"Miernik"},"uri":"/api/files/1261170"},"group_uuid":"31cce6ee-7996-4a9b-bd76-69e2ed70ebc4"}]},"dictionaries":{"announcement_status_draft":1,"announcement_status_published":2},"favorite":null,"badge":null,"offer_set_badge_count":null,"question_badge_count":null}}