Status:
COMPLETED
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Lead Sponsor:
Sealantium Medical Ltd.
Collaborating Sponsors:
Sintesi Research Srl
Home Medics Consulting Ltd.
Conditions:
Hemostasis
General Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
Detailed Description
Many products have been developed as adjuncts to hemostasis in bleeding situations where traditional methods such as suture, clips or energy-based coagulation are ineffective or impractical. Many pro...
Eligibility Criteria
Inclusion
- Patients (males or females) aged ≥ 18 years old.
- Patients requiring elective open hepatic surgery.
- Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure.
- Patients understanding the nature of the study and providing their informed consent prior to participation.
- Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol.
- Intra-operative inclusion criteria:
- Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).
Exclusion
- Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
- Patients with a severe coagulopathy defined as INR \> 2.0.
- Patients with platelet count \<50,000 x109 PLT/L at the screening.
- Patients admitted to trauma surgery.
- Transplant patients due to fulminant hepatic failure.
- Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator.
- Patients with anesthesia risk judged to be higher than ASA3 by the Investigator.
- Patients with at least one of the following concomitant conditions: severe co-morbid conditions known to pose a high risk for surgery and adequate recovery (i.e., liver cirrhosis with Child-Pugh score B or C, cholestasis, heart diseases), immunodeficiency diseases, blood clotting disorders, any conditions known to effect wound healing (i.e., collagen vascular disease), known or current alcohol or drug abusers.
- Patients suffering from claustrophobia.
- Patients with implanted or embedded metal objects, prostheses, pacemaker, or fragments in the head or body that would present a risk during the MRI scanning procedure or have worked with ferrous metals either as a vocation or hobby or following trauma (i.e., sheet metal workers, welders, or machinists) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field.
- Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents.
- Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.
- Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
- Intra-operative exclusion criteria:
- Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
- Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair.
- Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
- Patients having an active local infection in the anatomic surgical area.
- Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
- Patients with bleeding site in or near to foramina in bone.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04660721
Start Date
May 12 2021
End Date
May 18 2023
Last Update
March 21 2025
Active Locations (4)
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1
Washington University in St. Louis, School of Medicine, Department of Surgery
St Louis, Missouri, United States, 63100
2
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria, 4010
3
Medical University of Vienna, Department of Surgery Hepatobiliary Unit
Vienna, Austria, 1090
4
University Medical Center of Ljubljana, Division of Surgery
Ljubljana, Slovenia, 1000