- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03820713
Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
22. července 2020 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
30
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kaunas, Litva, LT-47144
- Kaunas Clinical Hospital
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Kaunas, Litva, LT-50009
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Komparátor placeba: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Treatment-emergent adverse event incidence
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Incidence of general surgical complications; incidence of minor adverse events
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Rafael Miller, MD, EIO Biomedical Ltd., Medical Adviser
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
9. května 2018
Primární dokončení (Aktuální)
15. července 2020
Dokončení studie (Aktuální)
15. července 2020
Termíny zápisu do studia
První předloženo
12. srpna 2018
První předloženo, které splnilo kritéria kontroly kvality
25. ledna 2019
První zveřejněno (Aktuální)
29. ledna 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. července 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. července 2020
Naposledy ověřeno
1. července 2020
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AOS-CL1000-02
- CL-PL-057-01 (Jiný identifikátor: EIO Biomedical Ltd.)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .