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

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Gallbladder Diseases; Intraoperative Bleeding; Hemorrhage, Surgical
• Intervention / Treatment: Device: GATT-Patch; Device: SURGICEL® Original

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Pennington, New Jersey, United States, 08534
      • Capital Health
  • New York
    • New York, New York, United States, 10065
      • Weill-Cornell
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health
  • Utah
    • Murray, Utah, United States, 84111
      • Intermountain Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

A subject must meet all of the following intra-operative inclusion criteria to be enrolled into 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
• 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
• Subject is currently participating or has participated in another clinical investigation within the past 30 days that may affect the endpoints of the study, such as trials related to the surgical procedure and anti-coagulation
• Subject is not appropriate for inclusion in the clinical investigation, per the medical opinion of the Investigator
• Subject has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GATT-Patch; Hemostatic Patch	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.
Active Comparator: SURGICEL® Original; Hemostatic Patch	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.; Other Names: Surgicel Absorbable Hemostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis	SBSS 0	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	SBSS 0	During surgical procedure
Median time in seconds to hemostasis from initiating pressure on the entire surface of the agent	SBSS 0	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	SBSS 0-5	During surgical procedure
Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent	SBSS 0	During surgical procedure
Treatment failure, defined as no hemostasis with the agent at 10 minutes from initiating pressure on the entire surface of the agent	SBSS 1-5 at the 10 minute timepoint	During surgical procedure
Rebleeding after the 10-minute time point from initiating pressure on the entire surface of the agent but before subject wound closure	SBSS 1-5 after initially SBSS 0	During surgical procedure
Number of times an additional (piece of) hemostatic agent needs to be used to achieve hemostasis	SBSS 1-5	During surgical procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration	Time in minutes	During surgical procedure
Rate of subjects requiring reoperation	Occurrence yes/no	During postoperative 3-months follow-up
Amount of hemostatic material needed versus bleeding surface	cm2 patch per cm2 bleeding	During surgical procedure
GATT-Patch device-specific user satisfaction questionnaire	Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome	At completion of the surgical procedure, at day 0
Conversion from minimally invasive to open surgery, and reasons for conversion	SBSS 1-5	During surgical procedure
Duration of hepatic blood inflow reduction	Time in minutes	During surgical procedure
Estimated blood loss during surgery	mL	During surgical procedure
Number and type of blood transfusions during hospitalization	Platelets, Erythrocytes, Plasma	During surgical procedure
Duration of Intensive Care Unit (ICU) stay	Time in Days	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Total hospitalization time	Time in Hours	From surgery to discharge from the ICU, estimated up to 30 days
Postoperative drainage volume, characteristics, and duration	Serous, sanguineous, serosanguineous, other Sanguineous Serosanguinous Serous, Sanguineous, Serosanguineous, Purulent, Other	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Rate of subjects with liver resection surface complications on ultrasound	Fluid collection, biloma, hematoma, patch encapsulation, patch rolling up on the surface	At 6 week follow-up visit

Collaborators and Investigators

• Sponsor: GATT Technologies BV
• Investigators: Study Director: Stuart Head, MD PhD, GATT Technologies BV

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• GATT Technologies B.V. website

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): August 5, 2025

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hemostasis; Liver surgery; Hemostatic patch; GATT-Patch; SURGICEL® Original; Gallbladder surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Hemorrhage; Biliary Tract Diseases; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Liver Diseases; Gallbladder Diseases; Blood Loss, Surgical
• Other Study ID Numbers: DHF-01-SP-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes