The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage (MIECH): An Open-label, Non-randomized, Single-arm Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Number of Adverse events (AEs), Serious Adverse Events (SAEs), and Unanticipated Device Effects (UDEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Number of Adverse events (AEs), Serious Adverse Events (SAEs), and Unanticipated Device Effects (UDEs)
Time Frame: 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
Rate of Mortality
Time Frame: 30 days
Safety will be assessed by determining mortality within 30 days post-operation for all subjects
Secondary Outcomes
- Hemorrhage volume(6 and 72 hours)
- Length of ICU(Number of days from admission, up to 180 days)
- modified Rankin Scale (mRS)(180 days)
- Glasgow Coma Scale (GCS)(180 days)
- Length of hospitalization(Number of days from admission to discharge, up to 180 days)
- Glasgow Outcome Scale Extended (GOSE)(180 days)