hemostasis uncontrolled bleeding
Conditions
Interventions
GATT-Patch is a resorbable hemostatic sealing patch, contained in a sterile
blister pack within a pouch, for topical use in internal surgery. It does not
require any special storage requirements. It
Sponsors
GATT Technologies BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Subject is scheduled to undergo an elective open surgery on the liver; * Subject is willing and able to give written informed consent for investigation participation; * Subject is 18 years of age or older at the time of enrollment; * 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 investigation: * 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 topical hemostat for control of hemostasis; * Subject has a target bleeding site with a SPOT GRADE of 1, 2, or 3
Exclusion criteria
Exclusion criteria: A subject must not meet any of the following pre-operative exclusion criteria to be enrolled into the clinical investigation: * Subject is scheduled to undergo surgery on other organs besides the liver (e.g. pancreas, colon, lungs); * Subject is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, (allowing exclusive use of acetylsalicylic acid);. * Subject has platelet count 100s, or international normalized ratio >2.5;. * Subject is pregnant, planning on becoming pregnant or actively breast-feeding during the follow-up period; * Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1); * Subject has an active or suspected infection at the surgical site; * Subject has a total bilirubin level of * 2.5 mg/dl * Subject has had or has planned to receive any organ transplantation; * Subject has American Association of Anesthesiologists (ASA) classification of 5; * Subject has a life expectancy of less than 3 months; * Subject has a documented severe congenital or acquired immunodeficiency; * Subject in whom the investigational device will be used at the site of a synthetic graft or patch implant; * Subject is currently participating or has participated in another clinical investigation within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; * 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 patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary performance endpoint The primary performance endpoint is defined by the percentage of cases achieving hemostasis at 3 minutes. Hemostasis will be defined by a grade of 0 (None/Dry) on the SPOT GRADE*, also known as the Surface Bleeding Severity Score (SBSS). The SPOT GRADE provides a validated score for assessment of bleeding at the target site, and consists of 6 subscales (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe; not immediately life-threatening, 5=extreme; immediately life threatening) (Spotniz, 2017). Investigators will be trained on the assessment scale prior to the investigation to have consistent assessment of bleeding at the target site. Achievement of hemostasis will be verified every 30 seconds. If hemostasis has not been achieved prior to site closure (SPOT GRADE 1-5), then treatment is considered a failure and additional hemostatic agents or techniques may be used. Safety objective and safety endpoints The safety of GATT-Patch will be assessed by the nature, severity and incidence of device-related adverse events. The adverse events found for GATT-Patch will be compared to the current knowledge and state of the art to assess whether the device is associated with acceptable safety outcomes. Adverse events may include: mortality, thromboembolic event, re-intervention, recurrent bleeding, biloma, blood transfusion, hematoma, surgical site infection, fever/pyrexia, allergic reaction, incapsulated device on ultrasound imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary performance endpoints * Mean time to hemostasis (seconds) * Percentage of hemostasis at 30, 60, 90, 120 and 150 seconds No formal hypothesis testing will be performed for the secondary objectives and endpoints of this clinical investigation. Exploratory endpoints In addition to the primary endpoint, the following exploratory endpoints will be recorded: surgery time (minutes), blood loss (mL) during surgery, blood Transfusion (mL) during hospitalization, SPOT GRADE (0-5) at the Target Bleeding Site (TBS), use of adjunct hemostatic agents/techniques (e.g. cautery, sutures or staples), amount of material needed versus bleeding surfaces, user satisfaction (questionnaire). | — |
Countries
Netherlands
Outcome results
None listed