MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracer… (NCT04839770) | Clinical Trial Compass
CompletedNot Applicable
MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage
Taiwan10 participantsStarted 2020-08-07
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Age 20-80 years, all genders/sexes are inclusive;
âś“. Evidence of a spontaneous basal ganglia ICH on CT scan;
âś“. Patient, or a family member with legally authorized responsibility, has given informed consent;
âś“. GCS of 6-14;
âś“. Volume of hematoma in range of 30-80 ml as measured by the ABC/2 method;
âś“. Can receive surgical treatment within 48 hours after ictus.
Exclusion criteria
âś•. Previous symptomatic stroke with neurological sequelae (per history or as seen on initial CT scan);
âś•. ICH known or suspected by study investigator to be secondary to aneurysm, vascular malformation, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, thrombolytic therapy, tumor, or infection;
âś•. Acute or active infection signs requiring treatment at the time of admission;
What they're measuring
1
Rate of Mortality
Timeframe: 30 days
2
Number of Adverse events (AEs), Serious Adverse Events (SAEs), and Unanticipated Device Effects (UDEs)
. Significant ventricular extension of the hemorrhage; more than 30 mL of intraventricular hemorrhage;
âś•. Refractory elevated ICP after placement of an EVD (external ventricular drain);
âś•. Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome;
âś•. Minimally invasive neurosurgery could not be commenced within 48 hours of onset. The case shall be excluded when the time of onset cannot be estimated and is judged with controversy by the investigator;
âś•. The hematological effects of any previous anticoagulants are not completely reversed (platelet count \< 100 Ă— 10\^3/ÎĽL; international normalized ratio (INR) \> 1.4);