NCT05900037CompletedNot Applicable
A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis During Minimally Invasive Liver and Gallbladder Surgery
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Patients will be blinded to randomized treatment and treatment used.
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Subject in whom the investigational device will be used at the site of a synthetic graft or patch implant
- •Subject has a life expectancy of less than 3 months
- •Subject has a documented severe congenital or acquired immunodeficiency
- •Subject has had or has planned to receive any organ transplantation
- •Subject undergoes surgery with the indication of being a living liver donor
- •Subject 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 anti-coagulation
- •Subject is not appropriate for inclusion in the clinical investigation, per the medical opinion of the Investigator
- •Subject has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the subject
Arms & Interventions
GATT-Patch
Experimental
Hemostatic Patch
Intervention: GATT-Patch (Device)
SURGICEL® Original
Active Comparator
Hemostatic Patch
Intervention: SURGICEL® Original (Device)
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)
Investigators
Study Sites (10)
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