gastroenterology &h epatology liver surgery
Conditions
Interventions
GATT-Patch and TachoSil will be used to control bleeding during liver surgery.
Each surgery will be performed according to the standard procedures of the
hospital, with exception of the use of GATT-
Sponsors
GATT Technologies BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Subject is scheduled to undergo elective open surgery on the liver; • Subject is willing and able to give written informed consent for the clinical investigation participation; • Subjects is 22 years of age or older at the time of enrollment; and • Subject has been informed of the nature of the clinical investigation. • Subject in whom the Investigator is able to identify a target bleeding site at the liver resection plane for which any applicable conventional means for hemostasis (e.g. suture, ligature or cautery) are ineffective or impractical, and the choice is made to use a hemostatic agent to stop the bleeding; and • Subject has a target bleeding site with a SBSS of 1, 2, or 3 (e.g. reflecting minimal, mild or moderate bleeding severities).
Exclusion criteria
Exclusion criteria: • The target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency; • Subject is scheduled to undergo surgery on other organs than the liver and its associated biliary and vascular system; • Subject is scheduled to undergo a staged liver surgery procedure (e.g., Associating Liver Partition and Portal vein ligation for Staged hepatectomy [ALPPS]) • Subject is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid; • Subject has platelet count 100s, or international normalized ratio >2.5; • Subject has a total bilirubin level of >=2.5 mg/dl; • Subject is pregnant, planning on becoming pregnant or actively breastfeeding during the 3-month follow-up period; • Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1), porcine gelatin, or horse proteins; • Subject who has religious objections to receiving products with components of animal (porcine or equine) or human origin; • Subject has an active or suspected infection at the bleeding site; • Subject in whom the investigational device will be used at the site of a synthetic graft or patch implant; • Subject has a life expectancy of less than 3 months; • Subject has a documented severe congenital or acquired immunodeficiency; • Subject has had or has planned to receive any organ transplantation; • Subject is currently participating or has participated in another clinical investigation within the past 30 days that may affect the endpoints of the study, such as trials related to the surgical procedure, and on anti-coagulation; • Subject is not appropriate for inclusion in the clinical investigation, per the medical opinion of the Investigator; and • Subject has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The primary efficacy endpoint is defined as non-inferiority of GATT-Patch compared to TachoSil in the percentage of cases achieving hemostasis at 3 minutes without rebleeding at the 10-minute time point. Hemostasis will be defined by a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale (SBSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints: • Median time to hemostasis (seconds); • Kaplan-Meier estimated distribution of time to hemostasis; • Treatment failure, defined as no hemostasis at 10 minutes; • Rebleeding after 10 minutes but before subject closure; and • Percentage of hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 480, 540, and 600 seconds. Safety endpoints: The safety of GATT-Patch will be assessed by the incidence, severity and relation to hemostatic device of all adverse events. The adverse events for the GATT-Patch group will be compared to those for the TachoSil group. Adverse events of special interest are bleeding-related events, thromboembolic events, biloma, and allergic reaction. Exploratory endpoints: • Procedure duration (minutes); • Estimated blood loss (mL) during surgery; • Number and type of blood transfusions during hospitalization; • Duration of Intensive Care Unit (ICU) stay; • Total hospitalization time; • Postoperative drainage volume, characteristics, and duration; • Need for and cause of reoperation; • Imaging of the liver resection at 6 weeks post-surgery to detect (1) fluid collection and its size (in mL) and aspect, (2) pseudo-aneurysm, (3) patch encapsulation, and (4) rolling up of the device on the resection plane; • Amount of hemostatic material needed versus bleeding surface; • User satisfaction (questionnaire) for GATT-Patch; • Physician treatment preference assessment (questionnaire); • Local recurrence of liver cancer at the resection; • Cancer-free survival; and • Overall survival. | — |
Countries
Netherlands
Outcome results
None listed