AzTrials
AzTrials

Intraoperative BleedingNCT05900037

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

A study testing GATT-Patch and SURGICEL® Original in people with Intraoperative Bleeding and Liver Diseases, run by GATT Technologies BV at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
GATT-Patch and SURGICEL® Original
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
6 sitesUnited States
Study dates
2 Oct 2023to 5 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Atrium Health

    Charlotte, North Carolina, 28204

  • University of Southern California

    Los Angeles, California, 90033

  • Intermountain Healthcare

    Murray, Utah, 84111

  • Weill-Cornell

    New York, New York, 10065

  • Capital Health

    Pennington, New Jersey, 08534

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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.

Being tested
GATT-Patch, SURGICEL® Original
Keywords
Hemostatic patch, GATT-Patch, SURGICEL® Original, Liver surgery, Gallbladder surgery, Hemostasis
Medical subject headings
Blood Loss, Surgical, Liver Diseases, Gallbladder Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GATT-PatchDevice

    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.

  • SURGICEL® OriginalDevice

    Also called Surgicel Absorbable Hemostat

    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.

Study groups in NCT05900037
Study groupRoleWhat they receive
GATT-PatchExperimentalHemostatic Patch
Receives: Device: GATT-Patch
SURGICEL® OriginalActive comparatorHemostatic Patch
Receives: Device: SURGICEL® Original

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During surgical procedure

Secondary outcomes (8)

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

    SBSS 0

    Measured: During surgical procedure

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

    SBSS 0

    Measured: During surgical procedure

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

    SBSS 0

    Measured: During surgical procedure

  4. 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

    Measured: During surgical procedure

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

    SBSS 0

    Measured: During surgical procedure

  6. 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

    Measured: During surgical procedure

  7. 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

    Measured: During surgical procedure

  8. Number of times an additional (piece of) hemostatic agent needs to be used to achieve hemostasis

    SBSS 1-5

    Measured: During surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start2 Oct 2023
  3. Primary completion7 Jul 2025
  4. Study completion5 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization 1:1
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05900037
Sponsor's protocol ID
DHF-01-SP-065
Status last verified
Feb 2026
First submitted
19 May 2023
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Undecided

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.

    PubMed 28699748

  • 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.

    PubMed 34536065

Questions about this trial

What is this clinical trial studying?

A study testing GATT-Patch and SURGICEL® Original in people with Intraoperative Bleeding and Liver Diseases, run by GATT Technologies BV at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: During surgical procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900037, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in