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GATT-Patch Versus TachoSil in Liver Surgery

NCT05385952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-03-04

Study results available
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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.

Conditions

Interventions

DEVICE

GATT-Patch (currently named ETHIZIA)

GATT-Patch (currently named ETHIZIA) 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.

DRUG

TachoSil

TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • GATT Technologies BV

    lead INDUSTRY

Principal Investigators

  • James Guarrera · Rutgers New Jersey Medical School, Newark, NJ, USA

  • Hans de Wilt · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2024-05-10
Completion
2024-05-10
FDA Device
Yes

Countries

  • United States
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385952 on ClinicalTrials.gov