GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery (NCT05900037) | Clinical Trial Compass
CompletedNot Applicable
GATT-Patch Versus SURGICEL® Original in Minimally Invasive Liver and Gallbladder Surgery
United States53 participantsStarted 2023-10-02
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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 associa…
What they're measuring
1
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