A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery
- Conditions
- gastroenterology &h epatologyliver surgery
- Registration Number
- NL-OMON53880
- Lead Sponsor
- GATT Technologies BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
• 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).
• 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 <100 x 109/L, an activated partial thrombin time
of >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint: The primary efficacy endpoint is defined as non-inferiority<br /><br>of GATT-Patch compared to TachoSil in the percentage of cases achieving<br /><br>hemostasis at 3 minutes without rebleeding at the 10-minute time point.<br /><br>Hemostasis will be defined by a grade of 0 (None/Dry) on the Surface Bleeding<br /><br>Severity Scale (SBSS).</p><br>
- Secondary Outcome Measures
Name Time Method