NCT04819945

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: GATT Technologies BV · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hemorrhage, Surgical

Interventions

Type	Name	Description
DEVICE	GATT-Patch	Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery

Timeline

• Start date: 2021-04-16
• Primary completion: 2022-01-18
• Completion: 2022-02-24
• First posted: 2021-03-29
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

3 sites across 1 country: Netherlands