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

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.

• GATT-Patch (Device): Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery

Primary outcomes

• Hemostasis [During procedure]: Performance of GATT-Patch in achieving hemostasis at 3 minutes

Secondary outcomes

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

Sex: All

Inclusion Criteria:

* 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;

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 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 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

Participant flow

Outcome results

• Hemostasis (Primary), Count of participants, Participants: GATT-Patch Stage II Patients 38; GATT-Patch All Patients 46
• Mean Time to Hemostasis (Seconds) (Secondary), Mean, seconds: GATT-Patch 54.6 +/- 107.5
• Hemostasis at Different Timepoints (Secondary), Number, participants: GATT-Patch Stage II Patients 32

Adverse events

Time frame: Adverse events were collected up to a 6-week (+ / - 2 weeks) follow-up visit.

Serious adverse events by term

Other adverse events by term

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 publication: 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 38640617
• Results publication: 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 36918896

• Study Protocol (PDF, 2021-04-28)
• Statistical Analysis Plan (PDF, 2021-09-17)

• 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