NCT05713955View on ClinicalTrials.gov

OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 1, 2028

Study Completion Date

April 1, 2029

Conditions
Anastomotic Leak Esophagus
Interventions
DEVICE

Obsidian

To create OBSiDiAN BioMatrix, 120 ml of the the patient's blood is added to the processing unit. The Vivostat® processor unit heats, separates, centrifugates to get the plasma. Batroxobin is added. After again processing, the result is an OBSiDian syringe filled with BioMatrix Obsidian®ASG. This will be applied on the anastomosis

Trial Locations (1)

9000

University Hospital Ghent, Ghent

All Listed Sponsors
collaborator

Vivostat

INDUSTRY

lead

University Hospital, Ghent

OTHER