Intraoperative Bleeding, Liver Diseases, Gallbladder Diseases, Hemorrhage, Surgical
Conditions
Keywords
Hemostatic patch, GATT-Patch, SURGICEL® Original, Liver surgery, Gallbladder surgery, Hemostasis
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.
Interventions
DEVICEGATT-Patch
GATT-Patch is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location. GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
DEVICESURGICEL® Original
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is indicated for use in surgical procedures to assist in the control of capillary, venous and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.
Sponsors
GATT Technologies BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to randomized treatment and treatment used.
Intervention model description
Randomization 1:1
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During surgical procedure | SBSS 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis | During surgical procedure | SBSS 0 |
| 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 | SBSS 0 |
| Median time in seconds to hemostasis from initiating pressure on the entire surface of the agent | During surgical procedure | SBSS 0 |
| 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 | SBSS 0-5 |
| Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent | During surgical procedure | SBSS 0 |
| 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 | SBSS 1-5 at the 10 minute timepoint |
| 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 | SBSS 1-5 after initially SBSS 0 |
| Number of times an additional (piece of) hemostatic agent needs to be used to achieve hemostasis | During surgical procedure | SBSS 1-5 |
Countries
United States
Contacts
STUDY_DIRECTORStuart Head, MD PhD
GATT Technologies BV
Outcome results
None listed