NCT04839770

MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage

The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage (MIECH): An Open-label, Non-randomized, Single-arm Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Clearmind Biomedical Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to provide preliminary safety data of minimally invasive endoscopic surgery using the Axonpen™ system for spontaneous intracerebral hemorrhage (ICH). The effectiveness of the Axonpen™ system in early hematoma removal and the surgical impact on subject's functional recovery will also be evaluated. The Axonpen™ system, consisting of a neuroendoscope (Axonpen) and a monitor (Axonmonitor), is cleared by FDA and indicated for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum.

Detailed description

In the present trial, the FDA-cleared Axonpen™ system was 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 neurosurgeons 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 the previous 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.

Conditions

• Intracerebral Hemorrhage
• Cerebral Hemorrhage
• Intracranial Hemorrhage
• Basal Ganglia Hemorrhage

Interventions

Type	Name	Description
DEVICE	Axonpen system	The Axonpen™ system, containing the Axonpen and the Axonmonitor, has been cleared for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum. The Axonpen is a neuroendoscope integrated with suction (sourced from hospital vacuum) and irrigation (sourced from third-party saline infusion bag) functions. The Axonmonitor is used for view and storage of the endoscopic image. The Axonpen™ system is intended to optimize the procedure of minimally invasive neurosurgery for early ICH evacuation.

Timeline

• Start date: 2020-08-07
• Primary completion: 2022-10-31
• Completion: 2023-01-31
• First posted: 2021-04-09
• Last updated: 2023-03-09

Locations

1 site across 1 country: Taiwan