{"status":"OK","data":{"advertisement":{"id":244157,"title":"Zapytanie ofertowe w trybie warunkowym dotycz\u0105ce opracowania metody klinicznej weryfikacji prototypu systemu wspomagaj\u0105cego niszczenie zmian nowotworowych w jamie brzusznej technikami ma\u0142oinwazyjnymi\n3/H4M/2024\nInquiry concerns the development of a method for spreading a prototype system for enhancing the destruction of lesions in the abdominal cavity using minimally invasive techniques\n3/H4M/2024","partial_offer_allowed":false,"publication_date":"2024-02-29","submission_deadline":"2024-03-07 14:00:00","planned_sign_date":null,"supplementary_orders":"ND","terms_of_contract_change":"Zamawiaj\u0105cy przewiduje mo\u017cliwo\u015b\u0107 zmiany postanowie\u0144 zawartej umowy, w szczeg\u00f3lno\u015bci w przypadku wyst\u0105pienia okoliczno\u015bci, kt\u00f3rych nie mo\u017cna by\u0142o przewidzie\u0107 w chwili zawarcia umowy, lub je\u017celi b\u0119d\u0105 one wynika\u0107 z wprowadzenia zmian w powszechnie obowi\u0105zuj\u0105cych przepisach prawa w zakresie, maj\u0105cym wp\u0142yw na realizacj\u0119 przedmiotu zam\u00f3wienia.\n\nW szczeg\u00f3lno\u015bci zmiany mog\u0105 dotyczy\u0107:\n\u25cf\tceny zam\u00f3wienia,\n\u25cf\tsposobu wynagrodzenia za wykonanie zam\u00f3wienia,\n\u25cf\tterminu wykonania zam\u00f3wienia,\n\u25cf\twarunk\u00f3w wykonania zam\u00f3wienia.\nPurchaser anticipates possibility of changes in the signed contract, especially when in case of unforseen circumstances or if they result from changes in law, which affect execution of the order.\n\nChanges might especially affect:\n\u25cf\tPrice of the order\n\u25cf\tTerms of payment\n\u25cf\tDeadline\n\u25cf\tConditions of recognizing contract as completed","created_at":"2024-02-29 13:59:07","modified_at":"2024-03-07 14:00:03","contact_persons":[{"id":64924,"forename":"Robert","surname":"Kr\u00f3l","phone_number":"","email":"robert.krol@holo4med.com","created_by":null,"created_at":"2024-02-29 13:59:07","modified_at":"2024-02-29 13:59:07","modified_by":null}],"orders":[{"id":396243,"estimated_value":null,"order_items":[{"id":446919,"description":"29.02.2024 Wprowadzono zmiany w tre\u015bci przedmiotu zam\u00f3wienia. Zmiany zosta\u0142y jasko zaznaczone na papierowych wersjach Zapytania Ofertowego.\n\nCelem jest opracowanie klinicznej metody weryfik. klinicznej prot. systemu wspomagaj\u0105cego niszczenie zmian nowotworowych w jamie brzusznej technikami ma\u0142oinwazyjnymi. Przedmiotem proj. b\u0119dzie stworzenie systemu nawigacji obrazowej wspomagaj\u0105cego niszczenie zmian ogniskowych w jamie brzusznej z wykorzystaniem rzeczywisto\u015bci mieszanej w technikach ma\u0142oinwazyjnych. Podczas diagnostyki przedoperacyjnej przygotowanie spersonalizowanego modelu anatomii jamy brzusznej pacjenta umo\u017cliwi \u0142atwiejsze i szybsze podejmowanie decyzji. W fazie planowania okre\u015bla si\u0119 pkt. wej\u015bcia, pkt. docelowy i potencjaln\u0105 trajektori\u0119 narz\u0119dzia chirurgicznego. Stworzony system pozwoli na uwypuklenie struktur anatomicznych, kt\u00f3re s\u0105 kluczowe dla bezpiecznego wykonania zabiegu. W trakcie terapii system umo\u017cliwi \u015br\u00f3doperacyjn\u0105 nawigacj\u0119 narz\u0119dzi chirurgicznych oraz wizualizacj\u0119 aktualnego po\u0142o\u017cenia narz\u0119dzi na tle modelu anatomicznego pacjenta. Przeprowadzenie badania klinicznego PROSPEKTYWNA OCENA PROCEDURY Z WYKORZYSTANIEM SYSTEMU INFO. RZECZYWISTO\u015aCI MIESZANEJ W RADIOLOGII INTERWENCYJNEJ na grupie 150 pacjent\u00f3w (50 grupa badana, 50grupa kontrolna) przez 12 miesi\u0119cy. Celem tego badania jest ocena bezpiecze\u0144stwa i wykonalno\u015bci procedury opartej na MR w por\u00f3wnaniu z konwencjonaln\u0105 fluoroskopi\u0105 TK w randomizowanym badaniu kontrolowanym.Pierwszorz\u0119dowy pkt. ko\u0144cowy skuteczno\u015bci: Liczba powik\u0142a\u0144 podczas zabieg\u00f3w okre\u015blonych przez kryteria Europejskiego Towarzystwa Radiologicznego Sercowo-Naczyniowego i Interwencyjnego (CIRSE), mierzona w skali liczbowej\u2013liczby naturalne. Dane te b\u0119d\u0105 pozyskiwane z dokumentacji medycznej pacjenta.Drugorz\u0119dowy pkt. ko\u0144cowy skuteczno\u015bci: Nara\u017cenie pacjenta na promieniowanie. Dawka otrzymana przez pacjenta podczas interwencyjnej procedury radiologicznej, r\u00f3wnie\u017c mierzona w ci\u0105g\u0142ej skali numerycznej w miligrayach razy centymetry (DLP - Dose Length Product).Info. te b\u0119d\u0105 pochodzi\u0107 z dok. medycznej radiologicznego post\u0119powania interwencyjnego - odczyt\u00f3w z tomografu komp. Nara\u017cenie personelu na promieniowanie. Dawka otrzymana przez personel wykonuj\u0105cy interwencyjn\u0105 procedur\u0119 radiologiczn\u0105, mierzona w ci\u0105g\u0142ej skali numerycznej w miligraiach razy centymetr (DLP - Dose Length Product). Dane te zostan\u0105 pozyskane z dok.i radiologicznej post\u0119powania interwencyjnego \u2013 odczyt\u00f3w z tomografu komputerowego.Czas trwania interwencyjnej procedury radiologicznej (w sekundach). Definiuje si\u0119 j\u0105 jako odst\u0119p czasu mierzony od momentu rozpocz\u0119cia wprowadzania ig\u0142y ablacyjnej do cia\u0142a pacjenta do zako\u0144czenia pierwszej fazy nagrzewania. Czas trwania interwencyjnego zabiegu radiologicznego uzyskuje si\u0119 z dokumentacji medycznej.W przypadku pierwszorz\u0119dowego pkt. ko\u0144cowego skuteczno\u015bci warto\u015bci liczbowe b\u0119d\u0105 zbierane w ci\u0105gu 30 dni po zabiegu. Gromadzenie danych b\u0119dzie prowadzone przez lekarza, kt\u00f3ry skierowa\u0142 pacjenta na radiologiczny zabieg interwencyjny lub przez lekarza podstawowej opieki zdrowotnej pacjenta poprzez kont. tel. Warto\u015bci liczbowe zwi\u0105zane z drugorz\u0119dowymi pkt. ko\u0144cowymi skuteczno\u015bci b\u0119d\u0105 zbierane jednorazowo przez personel wykonuj\u0105cy radiologiczn\u0105 procedur\u0119 interwencyjn\u0105 podczas tworzenia dok. medycznej.\nW ramach bada\u0144 nale\u017cy zrealizowa\u0107:\n1. Organizacja zespo\u0142u badawczego w o\u015brodku, w sk\u0142ad kt\u00f3rego wejd\u0105: kierownik projektu, wsp\u00f3\u0142wykonawcy, koordynator o\u015brodka badania, os. wprowadzaj\u0105ca dane do eCRF \n2.Bezpo\u015bredni udzia\u0142 lub nadz\u00f3r nad poszczeg\u00f3lnymi etapami badania klinicznego w o\u015brodku, a mianowicie: rekrut. pacjent\u00f3w do badania, uzyskanie \u015bwiadomej zgody; Rekrutacja pacjent\u00f3w do badania, wizyty kontrolne w badaniu\n3.Zapewnienie, \u017ce wizyta w celu wyboru o\u015brodka, wizyta inicjuj\u0105ca badania w o\u015brodku, systematyczne wizyty monitoruj\u0105ce badanie oraz wizyta zamykaj\u0105ca badania w o\u015brodku mog\u0105 by\u0107 przeprowadzane przez upowa\u017cnionych przedstawicieli Sponsora lub dedykowanych obserwator\u00f3w CRO\n4.Zapewnienie dost\u0119pu do ca\u0142ej dok. badania, w tym dok. o\u015brodka i dok. medycznej pacjenta, upowa\u017cnionym przedstawicielom Sponsora lub dedykowanym obserwatorom CRO\n5. Aktywny udzia\u0142 Kierownika Projektu albo jego przedstawiciela we wszelkiego rodzaju wizytach w o\u015brodkach oraz realizacja zalece\u0144 po wizytach wydanych przez upowa\u017cnionych przedstawicieli Sponsora lub dedykowanych obserwator\u00f3w CRO\n6.Zapewnienie nadzoru administracyjnego nad przebiegiem badania w o\u015brodku, a mianowicie nad terminowo\u015bci\u0105 i kompletno\u015bci\u0105 dokumentacji oraz bie\u017c\u0105cym wprowadzaniem danych do eCRF.\n7. Bezpo\u015bredni udzia\u0142 lub wyznaczenie osoby odpowiedzialnej za komunikacj\u0119 z przedstawicielami Sponsora i dedykowanego CRO.\nThe aim of the work is to develop a clinical method for the clinical verification of a prototype of a system supporting the destruction of cancerous lesions in the abdominal cavity using minimally invasive techniques, which will enable the Ordering Party to apply for certification of the prototype as a medical device.The subject of the project entitled \"Innovative mixed reality in minimally invasive diagnostic and therapy of pathological lesions in abdominal cavity\" will be the creation of an image navigation system supporting the destruction of focal lesions in the abdominal cavity using mixed reality in minimally invasive techniques. Achieving the project's goal will enable the system to be used in key phases of the abdominal cancer treatment process. During preoperative diagnosis, the preparation of a personalized model of the patient's abdominal anatomy will enable easier and faster decision-making. During the planning phase of the procedure, the entry point, the target point and the potential trajectory of the surgical instrument are determined. The created system will make it possible to highlight anatomical structures that are crucial for the safe performance of the procedure. During the therapy (performing the procedure), the system will enable intraoperative navigation of surgical instruments and visualization of the current position of the instruments against the patient's anatomy model.Conducting a clinical trial PROSPECTIVE EVALUATION OF A PROCEDURE USING A MIXED REALITY INFORMATION SYSTEM IN INTERVENTIONAL RADIOLOGY on a group of 150 patients (75 study group, 75 control group) over a period of 18 months. The purpose of this study is to assess the safety and feasibility of an MR-based procedure compared to conventional CT fluoroscopy in a randomized controlled trial.Primary Efficacy Endpoint:Number of complications during the procedures defined by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) criteria, measured on a numerical scale\u2014natural numbers. This data will be obtained from the patient's medical records.Secondary Efficacy Endpoint:Radiation exposure to patient. The dose received by the patient during the interventional radiological procedure, also measured on a continuous numerical scale in milligray times centimeter (DLP - Dose Length Product). This information will be sourced from the \nmedical documentation of the radiological interventional procedure - readings from the CT scanner.Radiation exposure to personnel. The dose received by the personnel performing the interventional radiological procedure, measured on a continuous numerical scale in milligray times centimeter (DLP - Dose Length Product). This data will be obtained from the radiological documentation of the interventional procedure - readings from the CT scanner.\nDuration of the interventional radiological procedure (measured in seconds). This is defined as the time interval measured from the moment of initiating the insertion of the ablation needle into the patient's body to the completion of the first heating phase. The duration of the interventional radiological procedure is obtained from the medical documentation.For the Primary Efficacy Endpoint, numerical values will be collected over a 30-day post-procedure period. This data collection will be conducted by the physician who referred the patient for the radiological interventional procedure or by the patient's primary care physician through telephone contact. Numerical values related to Secondary Efficacy Endpoints will be collected once by the personnel performing the radiological interventional procedure during the creation of medical documentation\nAs part of the study, the following scope should be implemented:\n1. Organization of the research team at the site, which will include: the principal investigator, co-investigators, the center coordinator of the study, the person entering the data into the eCRF. Note: The option of combining functions in the study is allowed.\n2.Direct participation or supervision of the various stages of the clinical trial at the site, namely: recruitment of patients for the study, obtaining informed consent; enrolment of patients in the study, follow-up visits in the study\n3.Ensuring that the site's selection visit, site initiation visit, systematic study monitoring visits, and site closing visit can be conducted by authorized representatives of the Sponsor or dedicated CRO monitors\n4.Provide access to all study documentation, including center records and patient medical records, to authorized representatives of the Sponsor or dedicated CRO monitors\n5.Active participation of the Principal Investigator our staudy nursein all types of site visits and follow-up of recommendations following visits issued by authorized of the Sponsor or dedicated CRO monitors\n6.Ensuring administrative supervision over the course of the study at the centre, namely the timeliness and completeness of the documentation and the ongoing entry of data into the eCRF. Depending on the needs of the study \n7. Direct participation or appointment of a person responsible for communication with representatives of the Sponsor and the dedicated CRO","warranty_period":null,"cpv_items":[{"id":8512,"code":"73000000-2","name":"Us\u0142ugi badawcze i eksperymentalno-rozwojowe oraz pokrewne us\u0142ugi doradcze"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":null,"poviat":null,"commune":null,"locality":null,"created_by":null,"created_at":"2024-02-29 13:59:07","modified_at":"2024-02-29 13:59:07","modified_by":null,"id":500872,"type":{"id":2,"name":"ca\u0142a Polska"},"group_uuid":"82f15d15-ca9d-4c8e-be96-2925872bf50a"}],"participation_conditions":[{"id":1223834,"description":"\u2022\tZamawiaj\u0105cy wymaga do\u015bwiadczenia w diagnostyce pacjent\u00f3w z nowotworami jamy brzusznej w okresie 3 lat wstecz od terminu sk\u0142adania ofert. \n\u2022\tThe Ordering Party requires experience in diagnosing patients with abdominal cancer within 3 yeart from the deadline for submitting offers.","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2024-02-29 13:59:07","modified_at":"2024-02-29 13:59:07","modified_by":null,"group_uuid":"caeeca54-b5c6-49be-bae0-f3704e24406a"},{"id":1223835,"description":"\u2022\tZamawiaj\u0105cy wymaga \u017ceby oferent reprezentowa\u0142 szpital uniwersytecki, dysponuj\u0105cy zapleczem naukowym i admiracyjnym do przeprowadzania bada\u0144 klinicznych, kt\u00f3ry realizowa\u0142 co najmniej 2 badania kliniczne w okresie 5 lat od terminu sk\u0142adania ofert. \n\u2022\tRequires that the bidder represents a University hospital, equipped with a scientific and admiration base for the doctors located there, who have performer at least 2 clinical trals withn a period of 5 years from the end of the bids.","type":{"id":3,"name":"Potencja\u0142 techniczny"},"created_by":null,"created_at":"2024-02-29 13:59:07","modified_at":"2024-02-29 13:59:07","modified_by":null,"group_uuid":"5f03b4ec-85e6-4cd7-a984-eaf588c20bd5"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2024-02-29 13:59:07","modified_at":"2024-02-29 13:59:07","modified_by":null,"group_uuid":"8f0165f6-ec94-4372-b3e8-898642268c36"}],"evaluation_criteria":[{"id":680880,"price_criterion":true,"description":"Kryterium wyboru stanowi cena netto w PLN (waga przypisana do kryterium - 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