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Intracerebral HemorrhageNCT04839770

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

A study testing Axonpen system in people with Intracerebral Hemorrhage and Cerebral Hemorrhage, run by Clearmind Biomedical Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Axonpen system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteTaiwan
Study dates
7 Aug 2020to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital (Linkou Branch)

    Taoyuan, 333423

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Axonpen system
Keywords
Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracranial Hemorrhage, ICH, Stroke, Endoscopic Hematoma Evacuation, Minimally Invasive Surgery, Endoscopic Neurosurgery
Medical subject headings
Cerebral Hemorrhage, Intracranial Hemorrhages, Basal Ganglia Hemorrhage, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axonpen systemDevice

    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.

Study groups in NCT04839770
Study groupRoleWhat they receive
AxonpenExperimentalSubjects will receive minimally invasive endoscopic surgery using the Axonpen™ system for early hematoma evacuation (within 48 hours post-ictus).
Receives: Device: Axonpen system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Mortality

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

    Measured: 30 days

  2. 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

    Measured: 180 days

Secondary outcomes (6)

  1. Hemorrhage volume

    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

    Measured: 6 and 72 hours

  2. Glasgow Coma Scale (GCS)

    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)

    Measured: 180 days

  3. modified Rankin Scale (mRS)

    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)

    Measured: 180 days

  4. Glasgow Outcome Scale Extended (GOSE)

    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)

    Measured: 180 days

  5. Length of ICU

    Duration of stay in the ICU

    Measured: Number of days from admission, up to 180 days

  6. Length of hospitalization

    Duration of stay in the hospital

    Measured: Number of days from admission to discharge, up to 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start7 Aug 2020
  3. Primary completion31 Oct 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04839770
Sponsor's protocol ID
MIECH-2020-01
Status last verified
Mar 2023
First submitted
31 Mar 2021
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 21456936

Questions about this trial

What is this clinical trial studying?

A study testing Axonpen system in people with Intracerebral Hemorrhage and Cerebral Hemorrhage, run by Clearmind Biomedical Inc. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04839770, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.

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