CompletedPhase 1/2

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

United States, Austria, Slovenia33 participantsStarted 2021-05-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.
✕. 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.
✕

What they're measuring

To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...

Timeframe: From visit 1 to visit 9 (an average of 6.5 months)

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

Timeframe: From visit 1 to visit 9 (an average of 6.5 months)

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

Timeframe: From visit 1 to visit 9 (an average of 6.5 months)

Trial details

NCT IDNCT04660721

SponsorSealantium Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-18

Results submitted2024-12-30

View on ClinicalTrials.gov More Hemostasis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.
✕. 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.
✕

What they're measuring

To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...

Timeframe: From visit 1 to visit 9 (an average of 6.5 months)

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

Timeframe: From visit 1 to visit 9 (an average of 6.5 months)