Trials / Completed
CompletedNCT04660721
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Sealantium Medical Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-05-12
- Primary completion
- 2023-05-18
- Completion
- 2023-05-18
- First posted
- 2020-12-09
- Last updated
- 2025-03-21
- Results posted
- 2025-03-21
Locations
4 sites across 3 countries: United States, Austria, Slovenia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04660721. Inclusion in this directory is not an endorsement.