At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
sFilm-FS +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating sFilm-FS and TACHOSIL® for Hemostasis and General Surgery. Completed, enrolled 33 participants across 4 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis, General Surgery
CountriesAustria, Slovenia, United States
CollaboratorsSintesi Research Srl, Home Medics Consulting Ltd.
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartMay 2021
Primary CompletionMay 2023
TodayJul 2026
First PostedDec 9, 2020
Enrollment StartMay 12, 2021
Primary CompletionMay 18, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.6 years ago
Interventions
sFilm-FScombination
sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
TACHOSIL®combination
TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.