Status:
COMPLETED
MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage
Lead Sponsor:
Clearmind Biomedical Inc.
Collaborating Sponsors:
Chang Gung Memorial Hospital
Conditions:
Intracerebral Hemorrhage
Cerebral Hemorrhage
Eligibility:
All Genders
20-80 years
Phase:
NA
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 effecti...
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 ...
Eligibility Criteria
Inclusion
- Patients who fulfill ALL the inclusion criteria will be enrolled:
- Age 20-80 years, all genders/sexes are inclusive;
- Evidence of a spontaneous basal ganglia ICH on CT scan;
- Patient, or a family member with legally authorized responsibility, has given informed consent;
- GCS of 6-14;
- Volume of hematoma in range of 30-80 ml as measured by the ABC/2 method;
- Can receive surgical treatment within 48 hours after ictus.
Exclusion
- Patients who fulfill ANY ONE of the exclusion criteria should not be enrolled:
- Previous symptomatic stroke with neurological sequelae (per history or as seen on initial CT scan);
- 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;
- Acute or active infection signs requiring treatment at the time of admission;
- Significant ventricular extension of the hemorrhage; more than 30 mL of intraventricular hemorrhage;
- Refractory elevated ICP after placement of an EVD (external ventricular drain);
- Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome;
- 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;
- The hematological effects of any previous anticoagulants are not completely reversed (platelet count \< 100 × 10\^3/μL; international normalized ratio (INR) \> 1.4);
- Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency;
- Any condition that could impose hazards to the patient with the MIN or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator;
- Major surgery within the preceding 14 days which poses risk in the opinion of the investigator;
- Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 12 months, including clinical, ECG, laboratory, or imaging findings;
- Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, antiplatelet agents, or oral anticoagulation (e.g., warfarin, factor Xa inhibitor, thrombin inhibitor) within the previous 14 days, irrespective of laboratory values;
- Pregnancy, breast-feeding, or positive pregnancy test (either serum or urine) (Woman of child-bearing potential must have a negative pregnancy test prior to the study procedure.);
- Participation in any investigational study in the last 30 days;
- Known terminal illness or planned withdrawal of care or comfort care measures.
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04839770
Start Date
August 7 2020
End Date
January 31 2023
Last Update
March 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chang Gung Memorial Hospital (Linkou Branch)
Taoyuan District, Taiwan, 333423