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

NCT05900037 | Completed DMC FDA Device

• 1 other identifier: DHF-01-SP-065
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 6

Brief 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; Gallbladder Diseases; Hemorrhage, Surgical; Liver Diseases

Keywords

Hemostatic patch; GATT-Patch; SURGICEL® Original; Liver surgery; Gallbladder surgery; Hemostasis

Outcome Measures

Primary Outcomes (1)

• Rate of hemostasis within 7 minutes from introduction of the first (piece of) patch through the trocar without rebleeding at the 10-minute time point from initiating pressure on the entire surface of the hemostatic agent

  SBSS 0

  During surgical procedure

Secondary Outcomes (8)

• Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis

  During surgical procedure

• Median time in seconds from introducing the hemostatic agent through the trocar to initiating pressure on the entire surface of the agent

  During surgical procedure

• Median time in seconds to hemostasis from initiating pressure on the entire surface of the agent

  During surgical procedure

• Percentage of hemostasis from initiating pressure on the entire surface of the agent at 30, 60, 120, 180, 240, 300, 360, 420, 480, 540 and 600 seconds

  During surgical procedure

• Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent

  During surgical procedure

Other Outcomes (12)

• Conversion from minimally invasive to open surgery, and reasons for conversion

  During surgical procedure

• Procedure duration

  During surgical procedure

• Duration of hepatic blood inflow reduction

  During surgical procedure

Study Arms (2)

GATT-Patch

EXPERIMENTAL

Hemostatic Patch

Device: GATT-Patch

SURGICEL® Original

ACTIVE COMPARATOR

Hemostatic Patch

Device: SURGICEL® Original

Interventions

GATT-Patch DEVICE

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.

GATT-Patch

SURGICEL® Original DEVICE

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.

Also known as: Surgicel Absorbable Hemostat

SURGICEL® Original

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Subject in whom the investigational device will be used at the site of a synthetic graft or patch implant
• Subject has a life expectancy of less than 3 months
• Subject has a documented severe congenital or acquired immunodeficiency
• Subject has had or has planned to receive any organ transplantation
• Subject undergoes surgery with the indication of being a living liver donor

Sponsors & Collaborators

• GATT Technologies BV: lead

Study Sites (6)

University of Southern California

Los Angeles, California, 90033, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Capital Health

Pennington, New Jersey, 08534, United States

Location

Weill-Cornell

New York, New York, 10065, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Intermountain Healthcare

Murray, Utah, 84111, United States

Location

Related Publications (2)

• 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.

  PMID: 28699748 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.

  PMID: 34536065 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical; Liver Diseases; Gallbladder Diseases

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Digestive System Diseases; Biliary Tract Diseases

Study Officials

• Stuart Head, MD PhD

  GATT Technologies BV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to randomized treatment and treatment used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization 1:1

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 12, 2023
• Study Start: October 2, 2023
• Primary Completion: July 7, 2025
• Study Completion: August 5, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (6)