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

NCT04839770 | Completed

• 1 other identifier: MIECH-2020-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage; Basal Ganglia Hemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of Mortality

  Safety will be assessed by determining mortality within 30 days post-operation for all subjects

  30 days

• Number of Adverse events (AEs), Serious Adverse Events (SAEs), and Unanticipated Device Effects (UDEs)

  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

  180 days

Secondary Outcomes (6)

• Hemorrhage volume

  6 and 72 hours

• Glasgow Coma Scale (GCS)

  180 days

• modified Rankin Scale (mRS)

  180 days

• Glasgow Outcome Scale Extended (GOSE)

  180 days

• Length of ICU

  Number of days from admission, up to 180 days

Study Arms (1)

Axonpen

EXPERIMENTAL

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

Device: Axonpen system

Interventions

Axonpen system DEVICE

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.

Axonpen

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Clearmind Biomedical Inc.: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Chang Gung Memorial Hospital (Linkou Branch)

Taoyuan District, 333423, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 21456936 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage; Intracranial Hemorrhages; Basal Ganglia Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Basal Ganglia Cerebrovascular Disease; Basal Ganglia Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 9, 2021
• Study Start: August 7, 2020
• Primary Completion: October 31, 2022
• Study Completion: January 31, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

TW (1)