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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage, Surgical
• Intervention / Treatment: Device: GATT-Patch

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud University Medical Center
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GATT-Patch; 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; Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GATT Technologies BV
• Collaborators: 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 record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): December 7, 2021
• Study Completion (ACTUAL): February 7, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (ACTUAL): March 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Hemostasis; Hemostatic patch; Surgical sealant; Open Liver Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: DHF-01-QR-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No