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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemorrhage, Surgical

Intervention / Treatment
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* Device: GATT-Patch


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GATT-Patch<br>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<br>* Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of GATT-Patch in achieving hemostasis at 3 minutes | 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). | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to hemostasis (seconds) | The mean time to hemostasis will be calculated based on time to hemostasis determined at 30 seconds intervals. | During procedure | 
| The number of participants achieving hemostasis at 30, 60, 90, 120 and 150 seconds. | The number of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined. | During procedure | 
| The percentage of participants achieving hemostasis at 30, 60, 90, 120 and 150 seconds. | The percentage of participants achieving hemostasis at 30, 60, 90, 120, and 150 seconds will be determined. | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostatic patch, Surgical sealant, Open Liver Surgery, Hemostasis