MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage

Not Applicable

Completed

• Conditions: Cerebral Hemorrhage; Intracerebral Hemorrhage; Basal Ganglia Hemorrhage; Intracranial Hemorrhage
• Interventions: Device: Axonpen system

• Registration Number: NCT04839770
• Lead Sponsor: Clearmind Biomedical Inc.

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 Timeline

• Study Start: 2020-08-07
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Primary Completion: 2022-10-31
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 exclusion criteria should not be enrolled:

1. Previous symptomatic stroke with neurological sequelae (per history or as seen on initial CT scan);
2. 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;
3. Acute or active infection signs requiring treatment at the time of admission;
4. Significant ventricular extension of the hemorrhage; more than 30 mL of intraventricular hemorrhage;
5. Refractory elevated ICP after placement of an EVD (external ventricular drain);
6. Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome;
7. 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;
8. The hematological effects of any previous anticoagulants are not completely reversed (platelet count < 100 × 10^3/μL; international normalized ratio (INR) > 1.4);
9. Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency;
10. 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;
11. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator;
12. Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 12 months, including clinical, ECG, laboratory, or imaging findings;
13. 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;
14. 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.);
15. Participation in any investigational study in the last 30 days;
16. Known terminal illness or planned withdrawal of care or comfort care measures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Axonpen	Axonpen system	Subjects will receive minimally invasive endoscopic surgery using the Axonpen™ system for early hematoma evacuation (within 48 hours post-ictus).

Primary Outcome Measures

Name	Time	Method
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
Rate of Mortality	30 days	Safety will be assessed by determining mortality within 30 days post-operation for all subjects

Secondary Outcome Measures

Name	Time	Method
Length of ICU	Number of days from admission, up to 180 days	Duration of stay in the ICU
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
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 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)
Length of hospitalization	Number of days from admission to discharge, up to 180 days	Duration of stay in the hospital
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)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital (Linkou Branch); 🇨🇳 Taoyuan, Taiwan