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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
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.
Chang Gung Memorial Hospital (Linkou Branch)
Taoyuan District, Taiwan
Rate of Mortality
Safety will be assessed by determining mortality within 30 days post-operation for all subjects
Time frame: 30 days
Number of Adverse events (AEs), Serious Adverse Events (SAEs), and Unanticipated Device Effects (UDEs)
AEs, SAEs, and UDEs will be observed from the beginning of the surgery until the last follow-up visit (Day 180) for safety monitoring, and their relation to the study device will be analyzed
Time frame: 180 days
Hemorrhage volume
Residual hematoma will be measured via 6 \& 72 hours post-operation CT. Reduction (%) of hemorrhage volume will be assessed by comparing with pre-operation CT
Time frame: 6 and 72 hours
Glasgow Coma Scale (GCS)
Clinical assessment for level of consciousness and responsiveness before and after surgery (Assessed by the sum of E/V/M scores. E: Eye opening, 1 = None - 4 = Spontaneous. V: Verbal response, 1 = None - 5 = Normal conversation. M: Motor response, 1 = None - 6 = Normal)
Time frame: 180 days
modified Rankin Scale (mRS)
Functional outcomes will be measured via mRS at 72 hours and 7 days post-operation, hospital discharge, and 40, 90, 180 days follow-up visits (Scale ranges from 1 to 7, 1 = No symptoms - 7 = Dead)
Time frame: 180 days
Glasgow Outcome Scale Extended (GOSE)
Functional outcomes will be measured via GOSE at 72 hours and 7 days post-operation, hospital discharge, and 40, 90, 180 days follow-up visits (Scale ranges from 1 to 8, 1 = Death - 8 = Upper good recovery)
Time frame: 180 days
Length of ICU
Duration of stay in the ICU
Time frame: Number of days from admission, up to 180 days
Length of hospitalization
Duration of stay in the hospital
Time frame: Number of days from admission to discharge, up to 180 days
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