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Clinical Safety and Performance of GATT-Patch in Open Liver Surgery

Hemorrhage, Surgical Clinical Trial

Official title:
A Prospective, Multicenter, Single-arm, Clinical Investigation Evaluating the Safety and Performance of GATT-Patch for Hemostasis During Open Liver Surgery

Clinical Trial Summary

The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.

Clinical Trial Description

The GATT-Patch study is a prospective, single arm, multicenter, pre-market, first-in-man clinical investigation, that intents to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery. The clinical investigation will be carried out in a maximum of 7 sites in The Netherlands, treating an estimated total of 51 participants. All participants will be thoroughly screened and if found eligible, treated with GATT-Patch during open liver surgery. Participants will be followed for 6 weeks with an additional ultrasound assessment at the 6 week follow up visit. The participant enrolment period is expected to take approximately 6 months, with a total expected duration of the clinical investigation of approximately 8 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04819945
Study type Interventional
Source GATT Technologies BV
Contact
Status Completed
Phase N/A
Start date April 1, 2021
Completion date February 7, 2022
View Details
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