GATT-Patch Versus TachoSil in Liver Surgery

Summary

This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with TachoSil for the management of minimal, mild, or moderate bleeding during elective open liver surgery.

Timeline

Start

2022-08-04

Primary completion

2024-05-10

Completion

2024-05-10

Publications

• Background Boerman MA, Roozen E, Sanchez-Fernandez MJ, Keereweer AR, Felix Lanao RP, Bender JCME, Hoogenboom R, Leeuwenburgh SC, Jansen JA, Van Goor H, Van Hest JCM. Next Generation Hemostatic Materials Based on NHS-Ester Functionalized Poly(2-oxazoline)s. Biomacromolecules. 2017 Aug 14;18(8):2529-2538. doi: 10.1021/acs.biomac.7b00683. Epub 2017 Jul 25.
• Background Roozen EA, Warle MC, Lomme RMLM, Felix Lanao RP, van Goor H. New polyoxazoline loaded patches for hemostasis in experimental liver resection. J Biomed Mater Res B Appl Biomater. 2022 Mar;110(3):597-605. doi: 10.1002/jbm.b.34938. Epub 2021 Sep 18.
• Guarrera JV, Kaur N, Verhoef C, Zendejas I, Botha J, Fouraschen SMG, Paterno F, Pianka F, Porte RJ, Samstein B, Sher L, Wellen JR, Bender JCME, Fossan I, Head SJ, de Wilt JHW; ETHIZIA Open Liver Study Collaborator Group. Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled multicenter trial. HPB (Oxford). 2026 May 7:S1365-182X(26)00612-X. doi: 10.1016/j.hpb.2026.04.466. Online ahead of print.

Drugs

Indications