GATT-Patch Versus TachoSil in Liver Surgery (NCT05385952) | Clinical Trial Compass
CompletedNot Applicable
GATT-Patch Versus TachoSil in Liver Surgery
United States132 participantsStarted 2022-08-04
Plain-language summary
This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with TachoSil for the management of minimal, mild, or moderate bleeding during elective open liver surgery.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is scheduled to undergo elective open surgery on the liver;
* 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 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; and
* 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 other organs 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 acetylsalicyl…
What they're measuring
1
Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point
Timeframe: During surgical procedure, assessed up to 10 minutes after device application