The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
The GATT-Patch study is a prospective, single arm, multicenter, pre-market, first-in-man clinical investigation, that intents to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery. The clinical investigation will be carried out in a maximum of 7 sites in The Netherlands, treating an estimated total of 51 participants. All participants will be thoroughly screened and if found eligible, treated with GATT-Patch during open liver surgery. Participants will be followed for 6 weeks with an additional ultrasound assessment at the 6 week follow up visit. The participant enrolment period is expected to take approximately 6 months, with a total expected duration of the clinical investigation of approximately 8 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Hemostasis
Performance of GATT-Patch in achieving hemostasis at 3 minutes
Time frame: During procedure
Mean Time to Hemostasis (Seconds)
The mean time to hemostasis will be calculated based on time to hemostasis determined at 30 seconds intervals.
Time frame: During procedure
Hemostasis at Different Timepoints
The number of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined.
Time frame: During procedure
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