Hemorrhage, Surgical Trial in Nijmegen, Rotterdam, Groningen (GATT-Patch) (2025)

Study Description

Brief Summary

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

Detailed Description

The GATT-Patch study is a prospective, single arm, multicenter, pre-market, first-in-manclinical investigation, that intents to determine the clinical safety and performance ofGATT-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 screenedand if found eligible, treated with GATT-Patch during open liver surgery. Participants willbe followed for 6 weeks with an additional ultrasound assessment at the 6 week follow upvisit.

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

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

1. Performance of GATT-Patch in achieving hemostasis at 3 minutes [During procedure]

   The primary performance endpoint is defined as non-inferiority of GATT-Patch compared to the standard of care regarding the percentage of cases achieving hemostasis at 3 minutes. (i.e. demonstrate GATT-Patch is significantly greater than literature-based performance goal of 65.4 percent).

Secondary Outcome Measures

1. 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.

2. The number of participants achieving hemostasis at 30, 60, 90, 120 and 150 seconds. [During procedure]

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

3. The percentage of participants achieving hemostasis at 30, 60, 90, 120 and 150 seconds. [During procedure]

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

Eligibility Criteria

Criteria

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 investigationparticipation;

• 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 betreated with the investigational device:

• Participant in whom the Investigator is able to identify a target bleeding site at theliver 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 touse a topical hemostat for control of hemostasis; and the choice is made to use atopical 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 tothe 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-feedingduring 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 syntheticgraft or patch implant;

• Participant is currently participating or has participated in another clinicalinvestigation within the past 30 days that may affect the endpoints of the study, suchas trials related to the surgical procedure, and on anti-coagulation;

• Participant is not appropriate for inclusion in the clinical investigation, per themedical opinion of the Investigator;

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

Contacts and Locations

Locations

Sponsors and Collaborators

• GATT Technologies BV
• Avania

Investigators

• Study Director: Stuart Head, MD PhD, GATT Technologies BV
• Principal Investigator: Hans de Wilt, Prof. dr., Radboud University Medical Center
• Study Chair: Harry van Goor, Prof. dr., Radboud University Medical Center

Study Documents (Full-Text)

More Information

Publications