Basal Ganglia Hemorrhage, Cerebral Hemorrhage, Intracerebral Hemorrhage, Intracranial Hemorrhage
Conditions
Keywords
Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracranial Hemorrhage, ICH, Stroke, Endoscopic Hematoma Evacuation, Minimally Invasive Surgery, Endoscopic Neurosurgery
Brief 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.
Interventions
DEVICEAxonpen 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.
Sponsors
Chang Gung Memorial Hospital
Clearmind Biomedical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who fulfill ALL the inclusion criteria will be enrolled: 1. Age 20-80 years, all genders/sexes are inclusive; 2. Evidence of a spontaneous basal ganglia ICH on CT scan; 3. Patient, or a family member with legally authorized responsibility, has given informed consent; 4. GCS of 6-14; 5. Volume of hematoma in range of 30-80 ml as measured by the ABC/2 method; 6. Can receive surgical treatment within 48 hours after ictus.
Exclusion criteria
Patients who fulfill ANY ONE of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Mortality | 30 days | Safety will be assessed by determining mortality within 30 days post-operation for all subjects |
| Number of Adverse events (AEs), Serious Adverse Events (SAEs), and Unanticipated Device Effects (UDEs) | 180 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale (mRS) | 180 days | 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) |
| Glasgow Outcome Scale Extended (GOSE) | 180 days | 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) |
| Hemorrhage volume | 6 and 72 hours | 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 |
| Length of hospitalization | Number of days from admission to discharge, up to 180 days | Duration of stay in the hospital |
| Length of ICU | Number of days from admission, up to 180 days | Duration of stay in the ICU |
| Glasgow Coma Scale (GCS) | 180 days | 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) |
Countries
Taiwan
Outcome results
None listed