Back to resultsA Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Primary Purpose
Hemostasis, General Surgery
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
sFilm-FS
TACHOSIL®
Sponsored by
About this trial
This is an interventional treatment trial for Hemostasis focused on measuring Body fluid leakage, Liver, Parenchymal bleeding, Hepatic surgery, Fibrin sealant, Fibrin patch, Human Fibrinogen, Human Thrombin, Coagulation
Eligibility Criteria
Inclusion Criteria:
- 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.
- Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).
Exclusion Criteria:
- Patients undergoing a re-operative procedure.
- 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 (ref. 11).
- 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 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.
Sites / Locations
- Washington University in St. Louis, School of Medicine, Department of Surgery
- Ordensklinikum Linz GmbH Barmherzige SchwesternRecruiting
- Medical University of Vienna, Department of Surgery Hepatobiliary Unit
- University Medical Center of Ljubljana, Division of SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sFilm-FS
TACHOSIL®
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the evaluation of the incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the count of participants with abnormal vital signs
Vital signs (considered altogether):
blood pressure (mmHg) heart rate (beats/min) temperature (°C) respiratory rate (breaths/min)
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through physical examinations
Physical examination:the detection of the number of patients with clinical abnormalities in different body areas
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the count of participants with abnormal urine analysis values
Urine analysis (considered altogether): specific gravity, pH, glucose, protein, blood, ketones, microscopic examination
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the count of participants with abnormal blood / coagulation parameters profiles
Blood / coagulation parameters profiles (considered altogether): Hb, HC, MCH, MCHC, MCV, RBC, WBC, PLT, Fibrinogen, lactate, D-Dimer, AT, ESR, CRP, BUN, creatinine, uric acid, BIL, LDH, AST (SGOT), ALT (SGPT), Gamma-GT, Na, Ca, P, glucose, albumin, total protein
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the detection of antibodies against fibrin and thrombin
Measurement of plasma levels of antibodies against human fibrinogen and human thrombin
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the evaluation of the incidence of signs of systemic inflammation
Incidence of signs of systemic inflammation
Secondary Outcome Measures
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through the proportion of patients achieving hemostasis at TBS
Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through the incidence of re-treatment at the TBS
Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application)
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through time to Hemostasis from first product application
Time to Hemostasis from first product application (TTHP). Time to Hemostasis from patient randomization (TTHR) will be collected as well but will not be used as endpoint
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through the percentage of total patients that have achieved hemostasis
Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through incidence of treatment failure
Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time)
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure.
Incidence of transfusion requirements in the 6 months follow-up period
Full Information
NCT ID
NCT04660721
First Posted
November 12, 2020
Last Updated
March 3, 2022
Sponsor
Sealantium Medical Ltd.
Collaborators
Sintesi Research Srl
1. Study Identification
Unique Protocol Identification Number
NCT04660721
Brief Title
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Official Title
A Phase I/II, Randomized, Prospective, Controlled, Multi-center, Open-label, Two Arm Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Liver Bleeding During Elective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sealantium Medical Ltd.
Collaborators
Sintesi Research Srl
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 products are not as effective in the presence of active and/or brisk bleeding since the lack of sufficient adhesion strength allows forceful bleeding to simply "float" the products away from the bleeding tissue, prior to the achievement of full hemostasis.
The Study investigates a new product, sFilm-FS, aimed to help the control of body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemostasis, General Surgery
Keywords
Body fluid leakage, Liver, Parenchymal bleeding, Hepatic surgery, Fibrin sealant, Fibrin patch, Human Fibrinogen, Human Thrombin, Coagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sFilm-FS
Arm Type
Experimental
Arm Title
TACHOSIL®
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
sFilm-FS
Intervention Description
sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
Intervention Type
Combination Product
Intervention Name(s)
TACHOSIL®
Intervention Description
TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
Primary Outcome Measure Information:
Title
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the evaluation of the incidence of Treatment-Emergent Adverse Events
Description
Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)
Time Frame
Through study completion, an average of 6 months
Title
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the count of participants with abnormal vital signs
Description
Vital signs (considered altogether):
blood pressure (mmHg) heart rate (beats/min) temperature (°C) respiratory rate (breaths/min)
Time Frame
Through study completion, an average of 6 months
Title
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through physical examinations
Description
Physical examination:the detection of the number of patients with clinical abnormalities in different body areas
Time Frame
Through study completion, an average of 6 months
Title
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the count of participants with abnormal urine analysis values
Description
Urine analysis (considered altogether): specific gravity, pH, glucose, protein, blood, ketones, microscopic examination
Time Frame
Through study completion, an average of 6 months
Title
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the count of participants with abnormal blood / coagulation parameters profiles
Description
Blood / coagulation parameters profiles (considered altogether): Hb, HC, MCH, MCHC, MCV, RBC, WBC, PLT, Fibrinogen, lactate, D-Dimer, AT, ESR, CRP, BUN, creatinine, uric acid, BIL, LDH, AST (SGOT), ALT (SGPT), Gamma-GT, Na, Ca, P, glucose, albumin, total protein
Time Frame
Through study completion, an average of 6 months
Title
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the detection of antibodies against fibrin and thrombin
Description
Measurement of plasma levels of antibodies against human fibrinogen and human thrombin
Time Frame
Through study completion, an average of 6 months
Title
To evaluate the safety of sFilm-FS versus the active-comparator (TACHOSIL®) when used as adjunct to conventional hemostatic techniques during elective hepatic surgery through the evaluation of the incidence of signs of systemic inflammation
Description
Incidence of signs of systemic inflammation
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through the proportion of patients achieving hemostasis at TBS
Description
Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure
Time Frame
Day of surgery
Title
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through the incidence of re-treatment at the TBS
Description
Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application)
Time Frame
Day of surgery
Title
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through time to Hemostasis from first product application
Description
Time to Hemostasis from first product application (TTHP). Time to Hemostasis from patient randomization (TTHR) will be collected as well but will not be used as endpoint
Time Frame
Day of surgery
Title
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through the percentage of total patients that have achieved hemostasis
Description
Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes
Time Frame
Day of surgery
Title
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure through incidence of treatment failure
Description
Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time)
Time Frame
Day of surgery
Title
To preliminarily evaluate the hemostatic efficacy of sFilm-FS in controlling parenchymal bleeding during surgery, related to hemostasis and treatment failure.
Description
Incidence of transfusion requirements in the 6 months follow-up period
Time Frame
From surgery, up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).
Exclusion Criteria:
Patients undergoing a re-operative procedure.
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 (ref. 11).
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Horn, PhD
Phone
+972-733907000
Email
sara@sealantium-med.com
First Name & Middle Initial & Last Name or Official Title & Degree
Orgad Laub, Professor
Phone
+972-0544434387
Email
orgad@sealantium-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orgad Laub, Professor
Organizational Affiliation
Sealantium Medical Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Washington University in St. Louis, School of Medicine, Department of Surgery
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63100
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grant Bochicchio
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern
City
Linz
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helwig WUNDSAM, Professor
Phone
+43-73276777300
Email
Wundsam@ordensklinikum.at
First Name & Middle Initial & Last Name & Degree
Helwig WUNDSAM, Professor
Facility Name
Medical University of Vienna, Department of Surgery Hepatobiliary Unit
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Completed
Facility Name
University Medical Center of Ljubljana, Division of Surgery
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blaz TROTOVSEK, Professor
Phone
+386-040654330
Email
blaz.trotovsek@kclj.si
First Name & Middle Initial & Last Name & Degree
Blaz TROTOVSEK, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
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