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

Completed · Not applicable

Conditions studied: Intraoperative Bleeding, Liver Diseases, Gallbladder Diseases, Hemorrhage, Surgical

In brief

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.

Key facts

Study ID: NCT05900037
Run by: GATT Technologies BV
People needed: 53
Starts: 2023-10-02
Expected to finish: 2025-08-05
Last updated by the study team: 2026-02-12

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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.
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)

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
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

Where it is running

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

Full record on ClinicalTrials.gov

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