Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Basal Ganglia Hemorrhage
  • Cerebral Hemorrhage
  • Intracerebral Hemorrhage
  • Intracranial Hemorrhage
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 80 years
Gender
Both males and females

Description

In the present trial, the FDA-cleared Axonpen™ system will be applied on the ICH surgery. The Axonpen™ System is a neuroendoscope combined with the functions of hematoma aspiration and irrigation, aiming to minimize surgical brain injury, optimize surgical procedure, and be available for early hemat...

In the present trial, the FDA-cleared Axonpen™ system will be applied on the ICH surgery. The Axonpen™ System is a neuroendoscope combined with the functions of hematoma aspiration and irrigation, aiming to minimize surgical brain injury, optimize surgical procedure, and be available for early hematoma evacuation. The technique of minimally invasive endoscopic neurosurgery for ICH is still considered in development; however, a retrospective study [Kuo et al.] has shown that early and complete evacuation of ICH may lead to improved outcomes in selected patients, where the surgery utilized combination of the existing instruments, such as a rod-lens endoscope with irrigation system and a suction coagulator, to enable visualization, aspiration, and irrigation of the hematoma to be worked simultaneously. The technology employed and the results revealed in this study provide a proof of concept for the Axonpen™ system, and also imply that the current device could be safe and effective in the management of ICH.

Tracking Information

NCT #
NCT04839770
Collaborators
Chang Gung Memorial Hospital
Investigators
Not Provided