This is a pre-market, prospective, randomized (1:1), multicenter, pivotal clinical investigation. The purpose of this investigation is to determine the clinical performance of GATT-Patch as compared with SURGICEL® Original for the management of minimal, mild, or moderate bleeding during minimally invasive liver and gallbladder surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
53
GATT-Patch is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location. GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is indicated for use in surgical procedures to assist in the control of capillary, venous and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.
University of Southern California
Los Angeles, California, United States
Washington University
St Louis, Missouri, United States
Capital Health
Pennington, New Jersey, United States
Weill-Cornell
New York, New York, United States
Rate of hemostasis within 7 minutes from introduction of the first (piece of) patch through the trocar without rebleeding at the 10-minute time point from initiating pressure on the entire surface of the hemostatic agent
SBSS 0
Time frame: During surgical procedure
Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis
SBSS 0
Time frame: During surgical procedure
Median time in seconds from introducing the hemostatic agent through the trocar to initiating pressure on the entire surface of the agent
SBSS 0
Time frame: During surgical procedure
Median time in seconds to hemostasis from initiating pressure on the entire surface of the agent
SBSS 0
Time frame: During surgical procedure
Percentage of hemostasis from initiating pressure on the entire surface of the agent at 30, 60, 120, 180, 240, 300, 360, 420, 480, 540 and 600 seconds
SBSS 0-5
Time frame: During surgical procedure
Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent
SBSS 0
Time frame: During surgical procedure
Treatment failure, defined as no hemostasis with the agent at 10 minutes from initiating pressure on the entire surface of the agent
SBSS 1-5 at the 10 minute timepoint
Time frame: During surgical procedure
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Atrium Health
Charlotte, North Carolina, United States
Intermountain Healthcare
Murray, Utah, United States
Rebleeding after the 10-minute time point from initiating pressure on the entire surface of the agent but before subject wound closure
SBSS 1-5 after initially SBSS 0
Time frame: During surgical procedure
Number of times an additional (piece of) hemostatic agent needs to be used to achieve hemostasis
SBSS 1-5
Time frame: During surgical procedure