- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03820713
Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
22 lipca 2020 zaktualizowane przez: Eio Biomedical Ltd.
Prospective, Randomized, Double Blinded, Parallel, Controlled, Two-arm, Two-center Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
Evaluation of the feasibility, safety, initial efficacy and usability of FuseX Anti-Adhesion system toward further studies that will be powered to proved its safety and efficacy.
In addition, this initial study will serve to yield blood bank and surgeon feedback towards improving the system.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
30
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Kaunas, Litwa, LT-47144
- Kaunas Clinical Hospital
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Kaunas, Litwa, LT-50009
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion criteria
PREOPERATIVE INCLUSION
Preoperatively the patient must:
- Understand and be able to follow the requirements of the protocol including signing and dating an Ethics Committee approved Informed Consent prior to undergoing any protocol related procedures
- Patients undergoing any of the above procedures
- Male or female subjects > 18 years of age
- Subjects for whom a second abdominal surgery is planned within less than 12 months of the first surgical procedure
- BMI<40
INTRAOPERATIVE INCLUSION
During surgery the patient must require having one of the following surgeries performed on their person:
- Planned or emergency colonic resection surgery with temporary stoma creation due to colonic perforation, acute diverticulitis or colonic obstruction.
- Surgery for low rectal cancer - low anterior resection. This surgery includes resection of lower part of rectum, colo-anal anastomosis and protective ileostomy creation. Usually patient undergo second stage procedure closure of ileostomy in 1-3 months.
- Total proctocolectomy and a pelvic pouch with diverting ileostomy in cases of surgery for Ulcerative colitis. In this kind of surgery there is the intention to close the temporary ileostomy in 1-3 months.
- Creation of stoma due to infectious process or trauma in the peritoneum (such as Fournier gangrene, laceration of rectum, etc.)
Exclusion Criteria
PREOPERATIVE EXCLUSION
Preoperatively a patient must not:
- be unable to give their own written informed consent,
- be currently enrolled in another clinical study with drug or device related to adhesions or has participated in such a study within the last 30 days,
- have received or is expected to receive any other investigational product or technique belonging to the group of hemostats, adhesion reduction devices or other products, meshes, or other types of implants in the abdominal cavity within 30 days prior to or during enrolment,
- subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation for reasons other than rectal carcinoma.
- BMI≥40
- Subjects who have received selective factor Xa inhibitors and/or direct thrombin inhibitors within 24 hours prior to surgery.
- Patients taking immune system suppressants deemed by the surgeon to interfere with wound healing, Patients taking daily doses of corticosteroids exceeding 20mg within the prior 30 days are to be excluded. Patients requiring perioperative corticosteroid supplementation are not to be excluded.
- Patients with a known history of severe multiple drug allergies
- Patients who have a life expectancy of less than 6 months because of a medical condition or disease state
- Any patient with a medical condition or other serious condition which will interfere with compliance and/or ability to complete this study protocol or who in the opinion of the investigator would not be a good candidate for enrollment
INTRAOPERATIVE EXCLUSION
- Patients for whom it is known, prior to the initial procedure, that loop ileostomy or colostomy closure is not feasible for any reason
- Patients with peritoneal carcinomatosis
- Patients with endometriosis
- Use of hernia mesh in the first surgery.
- Subjects treated with hemostatic agents in which the sealant remains in the patient's body (e.g. Fibrin sealant).
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Investigational arm
Treatment group receives a concentrate of coagulation factors.
The device concentrates coagulation factors from donor plasma; the concentrate is applied to the surgical site intended to reduce the incidence, extent and severity of postoperative adhesions.
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The plasma concentrate of coagulation factors is applied to the surgical site.
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Komparator placebo: Control arm
Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma.
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Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Treatment-emergent adverse event incidence
Ramy czasowe: Within 30 days from the first surgery
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Incidence of adverse events related to treatment requiring any invasive procedure in the test group (who used blood plasma concentrate prepared using FuseX Anti-Adhesion System) compared to control group (who used normal saline processed by the same FuseX Anti-Adhesion System).
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Within 30 days from the first surgery
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Overall adverse event incidence
Ramy czasowe: Until the second surgery but not longer than 7 months
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Overall adverse event incidence will be evaluated by the presence and severity of adverse events and serious adverse events in the test group (who used blood plasma concentrate prepared using FuseX Anti-Adhesion System) vs. control group (who used normal saline processed by the same FuseX Anti-Adhesion System).
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Until the second surgery but not longer than 7 months
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Severity of new formed adhesions in the target region
Ramy czasowe: Through study completion, an average of 1 year
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Severity of new formed adhesions having its source in the target region will be assessed by a blinded surgeon during the second surgery by grading the adhesion severity for each region on a scale from 0 (no adhesions) to 3 (strong vascularized adhesions that require sharp dissection and cannot be separated without tissue damage).
The peritoneal cavity will be divided into 9 separate scoring regions.
A peritoneal adhesion index (PAI) (sum of scores for all the regions) will be calculated per each patient.
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Through study completion, an average of 1 year
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Usability as assessed by Surgeon questionnaire
Ramy czasowe: Through study completion, an average of 1 year
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a. Ease of application will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy).
b.
Percentage of coverage the entire defined surgical field.
c. mL of the materials used
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Through study completion, an average of 1 year
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Usability as assessed by Operator questionnaire
Ramy czasowe: Through study completion, an average of 1 year
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a. Ease of device use will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy).
b.
Device operation time
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Through study completion, an average of 1 year
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Incidence of general surgical complications; incidence of minor adverse events
Ramy czasowe: Until the second surgery but not longer than 7 months
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Incidence of general surgical complications including but not limited to:
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Until the second surgery but not longer than 7 months
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Usability of the device Instructions for Use (questionnaire)
Ramy czasowe: Through study completion, an average of 1 year
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Usability of the device user manual will be scored on a 5-point Likert scale (1 = very hard to 5 = very easy).
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Through study completion, an average of 1 year
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Rafael Miller, MD, EIO Biomedical Ltd., Medical Adviser
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
9 maja 2018
Zakończenie podstawowe (Rzeczywisty)
15 lipca 2020
Ukończenie studiów (Rzeczywisty)
15 lipca 2020
Daty rejestracji na studia
Pierwszy przesłany
12 sierpnia 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
25 stycznia 2019
Pierwszy wysłany (Rzeczywisty)
29 stycznia 2019
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
23 lipca 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 lipca 2020
Ostatnia weryfikacja
1 lipca 2020
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AOS-CL1000-02
- CL-PL-057-01 (Inny identyfikator: EIO Biomedical Ltd.)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .