- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03820713
Evaluation of the Feasibility, Safety, Initial Efficacy and Clinical Usability of FuseX Anti-Adhesion System
22. Juli 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kaunas, Litauen, LT-47144
- Kaunas Clinical Hospital
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Kaunas, Litauen, LT-50009
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Placebo-Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Treatment-emergent adverse event incidence
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Incidence of general surgical complications; incidence of minor adverse events
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Rafael Miller, MD, EIO Biomedical Ltd., Medical Adviser
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. Mai 2018
Primärer Abschluss (Tatsächlich)
15. Juli 2020
Studienabschluss (Tatsächlich)
15. Juli 2020
Studienanmeldedaten
Zuerst eingereicht
12. August 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. Januar 2019
Zuerst gepostet (Tatsächlich)
29. Januar 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
23. Juli 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Juli 2020
Zuletzt verifiziert
1. Juli 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AOS-CL1000-02
- CL-PL-057-01 (Andere Kennung: EIO Biomedical Ltd.)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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