An interventional study of GATT-Patch and SURGICEL® Original in Intraoperative Bleeding, Liver Diseases and Gallbladder Diseases, sponsored by GATT Technologies BV. Completed at 6 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by GATT Technologies BV · Not applicable, Interventional, and Treatment
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.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's enrollment of 53 is below the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →GATT Technologies BV is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A subject must meet all of the following intra-operative inclusion criteria to be enrolled into the clinical investigation:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemostatic Patch
Device: GATT-Patch
Hemostatic Patch
Device: SURGICEL® Original
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® 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
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
Time frame: During surgical procedure
Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis
SBSS 0
Time frame: 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
Time frame: During surgical procedure
Median time in seconds to hemostasis from initiating pressure on the entire surface of the agent
SBSS 0
Time frame: 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
Time frame: During surgical procedure
Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent
SBSS 0
Time frame: 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
Time frame: 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
Time frame: During surgical procedure
Number of times an additional (piece of) hemostatic agent needs to be used to achieve hemostasis
SBSS 1-5
Time frame: During surgical procedure
Conversion from minimally invasive to open surgery, and reasons for conversion
SBSS 1-5
Time frame: During surgical procedure
Procedure duration
Time in minutes
Time frame: During surgical procedure
Duration of hepatic blood inflow reduction
Time in minutes
Time frame: During surgical procedure
Estimated blood loss during surgery
mL
Time frame: During surgical procedure
Number and type of blood transfusions during hospitalization
Platelets, Erythrocytes, Plasma
Time frame: During surgical procedure
Duration of Intensive Care Unit (ICU) stay
Time in Days
Time frame: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Total hospitalization time
Time in Hours
Time frame: 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
Time frame: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Rate of subjects requiring reoperation
Occurrence yes/no
Time frame: During postoperative 3-months follow-up
Rate of subjects with liver resection surface complications on ultrasound
Fluid collection, biloma, hematoma, patch encapsulation, patch rolling up on the surface
Time frame: At 6 week follow-up visit
Amount of hemostatic material needed versus bleeding surface
cm2 patch per cm2 bleeding
Time frame: 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
Time frame: At completion of the surgical procedure, at day 0
Plan to share: Yes — Undecided
Ran from Oct 2023 to primary completion in Jul 2025, 21 months.
Of 40 interventional studies with no phase under Blood Loss, Surgical, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 21 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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GATT Technologies BV