CompletedNCT04819945Updated Sep 19, 2024Results posted

Clinical Safety and Performance of GATT-Patch in Open Liver Surgery

An interventional study of GATT-Patch in Hemorrhage, Surgical, sponsored by GATT Technologies BV. Completed at 3 sites in Netherlands. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by GATT Technologies BV · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 56
Allocation: Not applicable
Sex: All

Study summary

The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.

Read the detailed description

The GATT-Patch study is a prospective, single arm, multicenter, pre-market, first-in-man clinical investigation, that intents to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.

The clinical investigation will be carried out in a maximum of 7 sites in The Netherlands, treating an estimated total of 51 participants. All participants will be thoroughly screened and if found eligible, treated with GATT-Patch during open liver surgery. Participants will be followed for 6 weeks with an additional ultrasound assessment at the 6 week follow up visit.

The participant enrolment period is expected to take approximately 6 months, with a total expected duration of the clinical investigation of approximately 8 months.

Conditions studied

Hemorrhage, Surgical

Browse trials for

Blood Loss, Surgical 213

Keywords

Hemostatic patch
Surgical sealant
Open Liver Surgery
Hemostasis

In context

Blood Loss, Surgical

213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.

This study's enrollment of 56 is below the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.

Browse Blood Loss, Surgical studies →

Lead sponsor

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.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

Participant is scheduled to undergo an elective open surgery on the liver;
Participant is willing and able to give written for investigation participation;
Participant is 18 years of age or older at the time of enrollment;
Participant has been informed of the nature of the clinical investigation.

A participant must meet all of the following intraoperative inclusion criteria to be treated with the device:

Participant 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 topical hemostat for control of hemostasis; and the choice is made to use a topical hemostat for control of hemostasis;
Participant has a minimal, mild, or moderate target bleeding;

Exclusion criteria

Exclusion Criteria:

Participant is scheduled to undergo surgery on other organs besides the liver (e.g. pancreas, colon, lungs);
Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, allowing exclusive use of acetylsalicylic acid;
Participant has count \<100 x 10ˆ9/L, an activates partial thrombin time of >100s, or >2.5;
Participant is pregnant, planning on becoming pregnant or actively breast-feeding during the follow-up period;
Participant has a known to brilliant blue (FD\&C Blue #1);
Participant has an active or suspected infection at the surgical site;
Participant has a total level of ≥ 2.5 mg/dl
Participant has had or has planned to receive any organ transplantation;
Participant has American Association of Anesthesiologists (ASA) classification of 4/5;
Participant has a of less than 3 months;
Participant has a documented severe congenital or acquired immunodeficiency;
Participant in whom the device will be used at the site of a synthetic graft or patch implant;
Participant 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 on anti-coagulation;
Participant is not appropriate for inclusion in the clinical investigation, per the medical opinion of the Investigator;
Participant has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the patient

Terms in these criteria, in plain language(7)

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.

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.

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.

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.

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.

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.

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.

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 56 participants (actual)

Study arms

Experimental
GATT-Patch
GATT-Patch will be used to control bleeding during open liver surgery. Each surgery will be performed according to the standard procedures at the hospital, with the exception of the use of GATT-Patch.
Device: GATT-Patch

Interventions

DeviceGATT-Patch
Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery

What researchers measure

Primary outcomes

Hemostasis
Performance of GATT-Patch in achieving hemostasis at 3 minutes
Time frame: During procedure

Secondary outcomes

Mean Time to Hemostasis (Seconds)
The mean time to hemostasis will be calculated based on time to hemostasis determined at 30 seconds intervals.
Time frame: During procedure
Hemostasis at Different Timepoints
The number of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined.
Time frame: During procedure

Results

Posted Sep 19, 2024

Limitations and caveats

This was a single-arm trial comparing GATT-Patch to a literature-derived performance goal. A randomized controlled trial will provide further insights into the performance of GATT-Patch versus a standard of care hemostatic patch. The trial was performed at 3 sites and results may have been dependent on the experience of surgeons in using hemostatic agents.

Participant flow

A total of 56 patients provided informed consent. There were 47 patients that received GATT-Patch during surgery.

Participant flow — Overall Study
Milestone	GATT-Patch
Started	47
Completed	46
Not completed	1
Withdrew: Lost to follow-up	1

Outcome measures

PrimaryHemostasis

Performance of GATT-Patch in achieving hemostasis at 3 minutes

Time frame:: During procedure
Reported as:: Count of participants · Participants

Hemostasis
Participants	GATT-Patch Stage II Patients	GATT-Patch All Patients
Hemostasis	38	46

SecondaryMean Time to Hemostasis (Seconds)

The mean time to hemostasis will be calculated based on time to hemostasis determined at 30 seconds intervals.

Time frame:: During procedure
Reported as:: Mean · seconds

Mean Time to Hemostasis (Seconds)
seconds	GATT-Patch
Mean Time to Hemostasis (Seconds)	54.6 ± 107.5

SecondaryHemostasis at Different Timepoints

The number of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined.

Time frame:: During procedure
Reported as:: Number · participants

Hemostasis at Different Timepoints
participants	GATT-Patch Stage II Patients
Hemostasis at 30 seconds	32
Hemostasis at 1 minute	37
Hemostasis at 90 seconds	37
Hemostasis at 120 seconds	37
Hemostasis at 150 seconds	37
Hemostasis at 3 minutes	38

Adverse events

Collected over Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
GATT-Patch All Patients	0/47 (0%)	7/47 (14.9%)	14/47 (29.8%)

Most frequent serious events

Most frequent serious events
Event	GATT-Patch All Patients
Abdominal abscessInfections and infestations	2/47
Gastric perforationGastrointestinal disorders	1/47
BilomaHepatobiliary disorders	1/47
Hepatic failureHepatobiliary disorders	1/47
PneumoniaInfections and infestations	1/47
Bile leakageHepatobiliary disorders	1/47

Most frequent other events

Most frequent other events
Event	GATT-Patch All Patients
Biloma / bile leakageHepatobiliary disorders	10/47
Hepatic hematomaInjury, poisoning and procedural complications	4/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)	GATT-Patch
Mean	59.7 ± 13.2

Sex: Female, Male
Sex: Female, Male(Participants)	GATT-Patch
Female	14
Male	33

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	GATT-Patch
American Indian or Alaska Native	1
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	43
More than one race	0
Unknown or Not Reported	2

Previous abdominal surgery, %
Previous abdominal surgery, %(Participants)	GATT-Patch
Count of participants	29

Hereditary blood disorders, %
Hereditary blood disorders, %(Participants)	GATT-Patch
Count of participants	1

Hemoglobin, g/dL
Hemoglobin, g/dL(g/dL)	GATT-Patch
Mean	8.3 ± 0.8

Platelet count, 10^9/L
Platelet count, 10^9/L(10^9 platelets/L)	GATT-Patch
Mean	219.4 ± 79.1

Total bilirubin, umol/L
Total bilirubin, umol/L(umol/L)	GATT-Patch
Mean	9.3 ± 4.9

1 further baseline measures are reported on the registry.

Study locations

3 sites

Radboud University Medical Center
Nijmegen, Gelderland 6525 GA, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland 3015 GD, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands

References and documents

Publications

de Wilt JHW, Verhoef C, de Boer MT, Stommel MWJ, van der Plas-Kemper L, Garms LM, van der Zijden CJ, Head SJ, Bender JCME, van Goor H, Porte RJ. Clinical Safety and Performance of GATT-Patch for Hemostasis in Minimal to Moderate Bleeding During Open Liver Surgery. J Surg Res. 2024 Jun;298:316-324. doi: 10.1016/j.jss.2024.03.033. Epub 2024 Apr 18. PubMed 38640617 ↗
Roozen EA, Lomme RMLM, Calon NUB, Ten Broek RPG, van Goor H. Efficacy of a novel polyoxazoline-based hemostatic patch in liver and spleen surgery. World J Emerg Surg. 2023 Mar 14;18(1):19. doi: 10.1186/s13017-023-00483-x. PubMed 36918896 ↗

Study documents

Study protocol ↗ · Apr 28, 2021
Statistical analysis plan ↗ · Sep 17, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Jan 2022, 9 months.

Results were first posted in Sep 2024, 2 years 8 months after primary completion.

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 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 17, 2021
First posted: Mar 29, 2021
StartActual: Apr 16, 2021
Primary completionActual: Jan 18, 2022
CompletionActual: Feb 24, 2022
Results first posted: Sep 19, 2024
Last update: Sep 19, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04819945
Lead sponsor: GATT Technologies BV
Collaborators: Avania
Responsible party: Sponsor
First posted: Mar 29, 2021
Start date: Apr 16, 2021
Primary completion: Jan 18, 2022
Completion: Feb 24, 2022
Results posted: Sep 19, 2024
Last update: Sep 19, 2024

Study contacts

Stuart Head, MD PhD

study director · GATT Technologies BV

Hans de Wilt, Prof. dr.

principal investigator · Radboud University Medical Center

Harry van Goor, Prof. dr.

study chair · Radboud University Medical Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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