Clinical trial NCT05900037: GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery
Official title: A Prospective, Multicenter, Randomized Clinical Investigation Evaluating GATT-Patch for Hemostasis During Minimally Invasive Liver and Gallbladder Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Bleeding
Liver Diseases
Gallbladder Diseases
Hemorrhage, Surgical
Keywords: Hemostatic patch
GATT-Patch
SURGICEL® Original
Liver surgery
Gallbladder surgery
Hemostasis
Lead sponsor: GATT Technologies BV
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: 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
timeFrame: During surgical procedure
Secondary outcomes:
measure: Median time in seconds from introducing the hemostatic agent through the trocar and achieving hemostasis
timeFrame: During surgical procedure
measure: Median time in seconds from introducing the hemostatic agent through the trocar to initiating pressure on the entire surface of the agent
timeFrame: During surgical procedure
measure: Median time in seconds to hemostasis from initiating pressure on the entire surface of the agent
timeFrame: During surgical procedure
measure: 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
timeFrame: During surgical procedure
measure: Kaplan-Meier estimated distribution of time to hemostasis from initiating pressure on the entire surface of the agent
timeFrame: During surgical procedure
measure: Treatment failure, defined as no hemostasis with the agent at 10 minutes from initiating pressure on the entire surface of the agent
timeFrame: During surgical procedure
measure: Rebleeding after the 10-minute time point from initiating pressure on the entire surface of the agent but before subject wound closure
timeFrame: During surgical procedure
measure: Number of times an additional (piece of) hemostatic agent needs to be used to achieve hemostasis
timeFrame: During surgical procedure
Other outcomes:
measure: Conversion from minimally invasive to open surgery, and reasons for conversion
timeFrame: During surgical procedure
measure: Procedure duration
timeFrame: During surgical procedure
measure: Duration of hepatic blood inflow reduction
timeFrame: During surgical procedure
measure: Estimated blood loss during surgery
timeFrame: During surgical procedure
measure: Number and type of blood transfusions during hospitalization
timeFrame: During surgical procedure
measure: Duration of Intensive Care Unit (ICU) stay
timeFrame: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
measure: Total hospitalization time
timeFrame: From surgery to discharge from the ICU, estimated up to 30 days
measure: Postoperative drainage volume, characteristics, and duration
timeFrame: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
measure: Rate of subjects requiring reoperation
timeFrame: During postoperative 3-months follow-up
measure: Rate of subjects with liver resection surface complications on ultrasound
timeFrame: At 6 week follow-up visit
measure: Amount of hemostatic material needed versus bleeding surface
timeFrame: During surgical procedure
measure: GATT-Patch device-specific user satisfaction questionnaire
timeFrame: At completion of the surgical procedure, at day 0
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Pennington
country: United States
facility: Capital Health
state: New Jersey
city: New York
country: United States
facility: Weill-Cornell
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
affiliation: GATT Technologies BV
name: Stuart Head, MD PhD
role: STUDY_DIRECTOR
References:
citation: Boerman MA, Roozen E, Sanchez-Fernandez MJ, Keereweer AR, Felix Lanao RP, Bender JCME, Hoogenboom R, Leeuwenburgh SC, Jansen JA, Van Goor H, Van Hest JCM. Next Generation Hemostatic Materials Based on NHS-Ester Functionalized Poly(2-oxazoline)s. Biomacromolecules. 2017 Aug 14;18(8):2529-2538. doi: 10.1021/acs.biomac.7b00683. Epub 2017 Jul 25.
citation: Roozen EA, Warle MC, Lomme RMLM, Felix Lanao RP, van Goor H. New polyoxazoline loaded patches for hemostasis in experimental liver resection. J Biomed Mater Res B Appl Biomater. 2022 Mar;110(3):597-605. doi: 10.1002/jbm.b.34938. Epub 2021 Sep 18.