Hemorrhage, SurgicalNCT04819945

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

A study testing GATT-Patch in people with Hemorrhage, Surgical, run by GATT Technologies BV at 3 sites in Netherlands.

Completed

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

Trial 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 more about this study

Who is it for?: Any age
Conditions the study is for: Hemorrhage, Surgical
What is being tested?: GATT-Patch
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 3 sitesNetherlands
Study dates: 16 Apr 2021to 24 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participant is scheduled to undergo an elective open surgery on the liver;
Participant is willing and able to give written informed consent 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 investigational 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;

Who cannot join

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 platelet count <100 x 10ˆ9/L, an activates partial thrombin time of >100s, or international normalized ratio >2.5;
Participant is pregnant, planning on becoming pregnant or actively breast-feeding during the follow-up period;
Participant has a known hypersensitivity to brilliant blue (FD\&C Blue #1);
Participant has an active or suspected infection at the surgical site;

Show all 15Show fewer

Participant has a total bilirubin 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 life expectancy of less than 3 months;
Participant has a documented severe congenital or acquired immunodeficiency;
Participant in whom the investigational 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

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

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

Other trials in Netherlands

About this study

Official title: A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis During Open Liver Surgery

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: Hemorrhage, Surgical
Being tested: GATT-Patch
Keywords: Hemostatic patch, Surgical sealant, Open Liver Surgery, Hemostasis
Medical subject headings: Blood Loss, Surgical

What participants receive

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

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

Study groups in NCT04819945
Study group	Role	What they receive
GATT-Patch	Experimental	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. Receives: Device: GATT-Patch

What is being measured

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

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

Secondary outcomes (2)

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

Timeline

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

16 Apr 202124 Feb 2022

First posted29 Mar 2021
Study start16 Apr 2021
Primary completion18 Jan 2022
Study completion24 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hemorrhage, SurgicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04819945
Sponsor's protocol ID: DHF-01-QR-021
Status last verified: Apr 2024
First submitted: 17 Mar 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemorrhage, Surgical trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis During Open Liver Surgery
ClinicalTrials.gov ID: NCT04819945
Acronym / sponsor ID: DHF-01-QR-021
Conditions: Hemorrhage, Surgical
Keywords: Hemostatic patch, Surgical sealant, Open Liver Surgery, Hemostasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: GATT Technologies BVIndustry (pharma, biotech, devices)
Collaborators: Avania
Study start: 16 Apr 2021 (actual)
Primary completion: 18 Jan 2022 (actual)
Study completion: 24 Feb 2022 (actual)
First posted: 29 Mar 2021 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GATT-Patch	Experimental	Device: GATT-PatchGATT-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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Participant is scheduled to undergo an elective open surgery on the liver;
Participant is willing and able to give written informed consent 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 investigational device:

Key exclusion criteria (15 listed)

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 platelet count <100 x 10ˆ9/L, an activates partial thrombin time of >100s, or international normalized ratio >2.5;
Participant is pregnant, planning on becoming pregnant or actively breast-feeding during the follow-up period;
Participant has a known hypersensitivity to brilliant blue (FD\&C Blue #1);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GATT-PatchUse of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery	Device	GATT-Patch

Primary outcome

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

2 secondary outcomes

Mean Time to Hemostasis (Seconds)
Time frame: During procedure
Hemostasis at Different Timepoints
Time frame: During procedure

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GATT-Patch	47	46

Primary outcome: Hemostasis

Time frame: During procedure. Count of participants. Unit: Participants

Measure	GATT-Patch Stage II Patients n = 39	GATT-Patch All Patients n = 47
Value	38	46

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GATT-Patch All Patients	7 of 47 (14.9%)	14 of 47 (29.8%)	0 of 47

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38640617de 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.
Derived from this study: PubMed 36918896Roozen 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.

Related trials for Hemorrhage, Surgical

Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GATT-Patch in people with Hemorrhage, Surgical, run by GATT Technologies BV at 3 sites in Netherlands.

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 7 inclusion and 15 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hemostasis (time frame: During 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 NCT04819945, 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 19 Sep 2024.