A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis during Open Liver Surgery - GATT patch study

GATT Technologies BV0 sites47 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

January 18, 2022

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•\* Subject is scheduled to undergo an elective open surgery on the liver;
•\* Subject is willing and able to give written informed consent for
•investigation participation;
•\* Subject is 18 years of age or older at the time of enrollment;
•\* Subject has been informed of the nature of the clinical investigation.
•A subject must meet all of the following intra\-operative inclusion criteria to
•be enrolled into the 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

•A subject must not meet any of the following pre\-operative exclusion criteria
•to be enrolled into the clinical investigation:
•\* Subject is scheduled to undergo surgery on other organs besides the liver
•(e.g. pancreas, colon, lungs);
•\* Subject is taking multiple antithrombotic therapies in therapeutic dosage up
•to the time of surgery, (allowing exclusive use of acetylsalicylic acid);.
•\* Subject has platelet count \<100 x 109/L, an activates partial thrombin time
•of \>100s, or international normalized ratio \>2\.5;.
•\* Subject is pregnant, planning on becoming pregnant or actively breast\-feeding
•during the follow\-up period;