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A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

NCT04660721 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-03-21

Study results available
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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.

Conditions

  • Hemostasis
  • General Surgery

Interventions

COMBINATION_PRODUCT

sFilm-FS

sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.

COMBINATION_PRODUCT

TACHOSIL®

TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Sponsors & Collaborators

  • Sintesi Research Srl

    collaborator INDUSTRY

  • Home Medics Consulting Ltd.

    collaborator UNKNOWN

  • Sealantium Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Orgad Laub, Professor · Sealantium Medical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2023-05-18
Completion
2023-05-18
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04660721 on ClinicalTrials.gov