A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis During Minimally Invasive Liver and Gallbladder Surgery

GATT Technologies BV10 sites in 1 country53 target enrollmentOctober 2, 2023

ConditionsIntraoperative Bleeding Liver Diseases Gallbladder Diseases Hemorrhage, Surgical

InterventionsGATT-Patch SURGICEL® Original

Overview

Phase: Not Applicable
Intervention: GATT-Patch
Conditions: Intraoperative Bleeding
Sponsor: GATT Technologies BV
Enrollment: 53
Locations: 10
Primary Endpoint: Rate of hemostasis within 7 minutes from introduction of the first (piece of) patch through the trocar without rebleeding at the 10-minute time point from initiating pressure on the entire surface of the hemostatic agent
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a pre-market, prospective, randomized (1:1), multicenter, pivotal clinical investigation. The purpose of this investigation is to determine the clinical performance of GATT-Patch as compared with SURGICEL® Original for the management of minimal, mild, or moderate bleeding during minimally invasive liver and gallbladder surgery.

Registry

clinicaltrials.gov

Start Date

October 2, 2023

End Date

August 5, 2025

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GATT Technologies BV

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is scheduled to undergo elective minimally invasive (robotic or laparoscopic) surgery on the liver, including cholecystectomy
•Subject is willing and able to give written informed consent for the clinical investigation participation
•Subjects is 22 years of age or older at the time of enrollment; and
•Subject has been informed of the nature of the clinical investigation.
•A subject must meet all of the following intra-operative inclusion criteria to be enrolled into the clinical investigation:
•Subject undergoes a fully minimally invasive surgical approach without the use of a hand port at the time of randomization and application of the patch;
•Subject 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 hemostatic agent to stop the bleeding
•Pressure on the surface of the hemostatic agent can be applied with the minimally invasive instruments to achieve hemostasis
•Subject has a target bleeding site with a SBSS of 1, 2, or 3 (e.g. reflecting minimal, mild or moderate bleeding severities)

Exclusion Criteria

•The target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency
•Subject is scheduled to undergo surgery on organs other than the liver and its associated biliary and vascular system
•Subject is scheduled to undergo a staged liver surgery procedure (e.g., Associating Liver Partition and Portal vein ligation for Staged hepatectomy \[ALPPS\])
•Subject is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
•Subject has platelet count \<100 x 109/L, an activated partial thrombin time of \>100s, or international normalized ratio \>2.5
•Subject has a total bilirubin level of ≥2.5 mg/dl
•Subject is pregnant, planning on becoming pregnant or actively breastfeeding during the 3-month follow-up period
•Subject has a known hypersensitivity to brilliant blue (FD\&C Blue #1), porcine gelatin
•Subject who has religious objections to receiving products containing porcine
•Subject has an active or suspected infection at the bleeding site

Arms & Interventions

GATT-Patch

Hemostatic Patch

Intervention: GATT-Patch

SURGICEL® Original

Hemostatic Patch

Intervention: SURGICEL® Original

Outcomes

Primary Outcomes

Rate of hemostasis within 7 minutes from introduction of the first (piece of) patch through the trocar without rebleeding at the 10-minute time point from initiating pressure on the entire surface of the hemostatic agent

Time Frame: During surgical procedure

SBSS 0

Secondary Outcomes

Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis(During surgical procedure)
Percentage of hemostasis from initiating pressure on the entire surface of the agent at 30, 60, 120, 180, 240, 300, 360, 420, 480, 540 and 600 seconds(During surgical procedure)
Rebleeding after the 10-minute time point from initiating pressure on the entire surface of the agent but before subject wound closure(During surgical procedure)
Median time in seconds from introducing the hemostatic agent through the trocar to initiating pressure on the entire surface of the agent(During surgical procedure)
Median time in seconds to hemostasis from initiating pressure on the entire surface of the agent(During surgical procedure)
Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent(During surgical procedure)
Treatment failure, defined as no hemostasis with the agent at 10 minutes from initiating pressure on the entire surface of the agent(During surgical procedure)
Number of times an additional (piece of) hemostatic agent needs to be used to achieve hemostasis(During surgical procedure)