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GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery | Clinical Trials | Clareo Health

COMPLETEDNA

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

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis During Minimally Invasive Liver and Gallbladder Surgery

NCT05900037•GATT Technologies BV

View on ClinicalTrials.gov

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is scheduled to undergo elective minimally invasive (robotic or laparoscopic) surgery on the liver, including cholecystectomy
•Subject is willing and able to give written informed consent for the clinical investigation participation
•Subjects is 22 years of age or older at the time of enrollment; and
•Subject has been informed of the nature of the clinical investigation.
•Subject undergoes a fully minimally invasive surgical approach without the use of a hand port at the time of randomization and application of the patch;
•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, and the choice is made to use a hemostatic agent to stop the bleeding
•Pressure on the surface of the hemostatic agent can be applied with the minimally invasive instruments to achieve hemostasis
•Subject has a target bleeding site with a SBSS of 1, 2, or 3 (e.g. reflecting minimal, mild or moderate bleeding severities)

Exclusion Criteria

•The target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency
•Subject is scheduled to undergo surgery on organs other than the liver and its associated biliary and vascular system
•Subject is scheduled to undergo a staged liver surgery procedure (e.g., Associating Liver Partition and Portal vein ligation for Staged hepatectomy \[ALPPS\])
•Subject is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
•Subject has platelet count \<100 x 109/L, an activated partial thrombin time of \>100s, or international normalized ratio \>2.5
•Subject has a total bilirubin level of ≥2.5 mg/dl
•Subject is pregnant, planning on becoming pregnant or actively breastfeeding during the 3-month follow-up period
•Subject has a known hypersensitivity to brilliant blue (FD\&C Blue #1), porcine gelatin
•Subject who has religious objections to receiving products containing porcine
•Subject has an active or suspected infection at the bleeding site
+8 more criteria

Locations (6)

University of Southern California

Los Angeles, California, United States

Washington University

St Louis, Missouri, United States

Capital Health

Pennington, New Jersey, United States

Weill-Cornell

New York, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Intermountain Healthcare

Murray, Utah, United States

Key Dates

Start Date

October 2, 2023

Primary Completion Date

July 7, 2025

Completion Date

August 5, 2025

Last Updated

February 12, 2026

Enrollment

ACTUAL participants

Conditions

Intraoperative BleedingLiver DiseasesGallbladder DiseasesHemorrhage, Surgical

Interventions

GATT-Patch

DEVICE

SURGICEL® Original

DEVICE

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Liver Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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