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

• ClinicalTrials.gov Identifier: NCT04839770
• Recruitment Status: Recruiting
• First Posted: April 9, 2021
• Last Update Posted: March 10, 2022
• Sponsor: Clearmind Biomedical Inc.
• Collaborator: Chang Gung Memorial Hospital
• Information provided by (Responsible Party): Clearmind Biomedical Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intracerebral Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage; Basal Ganglia Hemorrhage	Device: Axonpen system	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage (MIECH): An Open-label, Non-randomized, Single-arm Pilot Study
• Actual Study Start Date: August 7, 2020
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm

Intervention/treatment

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

Device: Axonpen 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.

Outcome Measures

Primary Outcome Measures :

1. Rate of Mortality [ Time Frame: 30 days ]
   Safety will be assessed by determining mortality within 30 days post-operation for all subjects
2. 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

Secondary Outcome Measures :

1. Hemorrhage volume [ Time Frame: 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
2. Glasgow Coma Scale (GCS) [ Time Frame: 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)
3. modified Rankin Scale (mRS) [ Time Frame: 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)
4. Glasgow Outcome Scale Extended (GOSE) [ Time Frame: 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)
5. Length of ICU [ Time Frame: Number of days from admission, up to 180 days ]
   Duration of stay in the ICU
6. Length of hospitalization [ Time Frame: Number of days from admission to discharge, up to 180 days ]
   Duration of stay in the hospital

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Hsiu-Jen Lin, PhD; +886-2-22697417 ext 108; shaun@theclearmindgroup.com

Contact: Chun-Wei Yang; +886-2-22697417 ext 107; carrey@theclearmindgroup.com

Locations

Taiwan

Chang Gung Memorial Hospital (Linkou Branch); Recruiting

Taoyuan, Taiwan, 333423

Contact +886-3-3281200 ext 2412

Principal Investigator: Chi-Cheng Chuang, MD

Sponsors and Collaborators

Clearmind Biomedical Inc.

Chang Gung Memorial Hospital

More Information

Publications:

Kuo LT, Chen CM, Li CH, Tsai JC, Chiu HC, Liu LC, Tu YK, Huang AP. Early endoscope-assisted hematoma evacuation in patients with supratentorial intracerebral hemorrhage: case selection, surgical technique, and long-term results. Neurosurg Focus. 2011 Apr;30(4):E9. doi: 10.3171/2011.2.FOCUS10313.

• Responsible Party: Clearmind Biomedical Inc.
• ClinicalTrials.gov Identifier: NCT04839770
• Other Study ID Numbers: MIECH-2020-01
• First Posted: April 9, 2021
• Last Update Posted: March 10, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Clearmind Biomedical Inc.:

Intracerebral Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage; ICH; Stroke; Endoscopic Hematoma Evacuation; Minimally Invasive Surgery; Endoscopic Neurosurgery

Additional relevant MeSH terms:

Cerebral Hemorrhage; Intracranial Hemorrhages; Basal Ganglia Hemorrhage; Hemorrhage; Pathologic Processes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Basal Ganglia Cerebrovascular Disease; Basal Ganglia Diseases