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GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery

NCT05900037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Intraoperative Bleeding
  • Liver Diseases
  • Gallbladder Diseases
  • Hemorrhage, Surgical

Interventions

DEVICE

GATT-Patch

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.

DEVICE

SURGICEL® Original

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.

Sponsors & Collaborators

  • GATT Technologies BV

    lead INDUSTRY

Principal Investigators

  • Stuart Head, MD PhD · GATT Technologies BV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2025-07-07
Completion
2025-08-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT05900037 on ClinicalTrials.gov