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sFilm-FS for Hemostasis

Phase 1 & 2
Waitlist Available
Research Sponsored by Sealantium Medical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgery, up to 6 months
Awards & highlights

Study Summary

This trial looks at a new product to help control body fluid leakage during surgery. It is proposed as an adjunct to hemostasis (stopping bleeding) and/or sealing.

Eligible Conditions
  • Hemostasis
  • General Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgery, up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 physical examinations
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
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
+4 more
Secondary outcome measures
Hemorrhage
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
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
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: sFilm-FSExperimental Treatment1 Intervention
Group II: TACHOSIL®Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sFilm-FS
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Home Medics Consulting Ltd.UNKNOWN
Sealantium Medical Ltd.Lead Sponsor
Sintesi Research SrlIndustry Sponsor
15 Previous Clinical Trials
1,467 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Annals of SurgeryJournal
The Impact of Complications on Costs of Major Surgical Procedures
Vonlanthen, René, Ksenija Slankamenac, Stefan Breitenstein, Milo A. Puhan, Markus K. Muller, Dieter Hahnloser, Dimitri Hauri, Rolf Graf, and Pierre-Alain Clavien. 2011. “The Impact of Complications on Costs of Major Surgical Procedures”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e31821d4a43.
British Journal of SurgeryJournal
Comparison of a Single Layer Continuous Hand-sewn Method and Circular Stapling in 580 Oesophageal Anastomoses
Fok, M, A K Ah-Chong, S W K Cheng, and J Wong. 1991. “Comparison of a Single Layer Continuous Hand-sewn Method and Circular Stapling in 580 Oesophageal Anastomoses”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.1800780323.
World Journal of SurgeryJournal
Fibrin Sealant: Past, Present, and Future: A Brief Review
Spotnitz, William D.. 2009. “Fibrin Sealant: Past, Present, and Future: A Brief Review”. World Journal of Surgery. Springer Science and Business Media LLC. doi:10.1007/s00268-009-0252-7.
British Journal of SurgeryJournal
Topical Haemostatic Agents
Seyednejad, H, M Imani, T Jamieson, and A M Seifalian. 2008. “Topical Haemostatic Agents”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.6357.
~8 spots leftby Apr 2025
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