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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.

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)