Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach

1 country

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

March 17, 2021

Completed

12 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed

18 days until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2022

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed

Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

March 17, 2021

Results QC Date

January 25, 2023

Last Update Submit

April 22, 2024

Conditions

Hemorrhage, Surgical

Keywords

Hemostatic patchSurgical sealantOpen Liver SurgeryHemostasis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (1)

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.

Device: GATT-Patch

Interventions

GATT-PatchDEVICE

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

GATT-Patch

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.
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;

You may not qualify if:

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;
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 has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

GATT Technologies BVlead
Avaniacollaborator

Study Sites (3)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (2)

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.
PMID: 38640617DERIVED
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.
PMID: 36918896DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

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.

Results Point of Contact

Title: Dr Stuart Head, MD, PhD, Chief Medical Officer
Organization: GATT Technologies B.V.

Study Officials

Stuart Head, MD PhD
GATT Technologies BV
STUDY DIRECTOR
Hans de Wilt, Prof. dr.
Radboud University Medical Center
PRINCIPAL INVESTIGATOR
Harry van Goor, Prof. dr.
Radboud University Medical Center
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 29, 2021

Study Start

April 16, 2021

Primary Completion

January 18, 2022

Study Completion

February 24, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-04

Locations

NL(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

GATT-Patch

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations