Intracerebral HemorrhageNCT06843616
A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）
A study testing Endoscopic surgery in people with Intracerebral Hemorrhage, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
Trial summary
This clinical trial is a prospective, open-label, single-arm clinical trial. According to the inclusion and exclusion criteria specified in the trial protocol, no fewer than 16 subjects with cerebral hemorrhage will be enrolled in 1 to 2 clinical centers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Endoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years old;
- Spontaneous intracerebral hemorrhage;
- Hemorrhage located in the supratentorial subcortical or basal ganglia region;
- Hematoma volume ≥ 30ml and ≤ 80ml;
- Able to undergo surgery within 72 hours after onset;
- GCS score of 5 to 14;
- The subject themselves and/or their authorized representative can understand the purpose of the study, agree to participate, and sign the informed consent form.
Who cannot join
- History of intracerebral hemorrhage within the past year;
- Traumatic intracerebral hemorrhage;
- Multiple intracerebral hemorrhages;
- Note: Hemorrhage in the supratentorial subcortical or basal ganglia region that extends into the ventricles is not considered multiple hemorrhages and can be included.
- Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
- Formation of brain herniation;
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- Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);
- mRS score ≥ 3 before onset;
- Use of anticoagulants or antiplatelet drugs within 14 days before onset, or the need for long-term use of anticoagulants or antiplatelet drugs, or other factors causing coagulation dysfunction;
- Platelet count less than 100 × 10^3/μL or international normalized ratio (INR) greater than 1.4;
- Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;
- Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg after medication upon admission);
- Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;
- Women of childbearing age who are pregnant or breastfeeding;
- Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;
- Life expectancy ≤ 1 year;
- Other situations where the researcher deems the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
About this study
This clinical trial is a prospective, open-label, single-arm clinical trial. According to the inclusion and exclusion criteria specified in the trial protocol, no fewer than 16 subjects with cerebral hemorrhage will be enrolled in 1 to 2 clinical centers. Considering the learning period required for doctor to become proficient in using the device, the first three cases at each research center are considered as the lead-in period cases and will not be included in the primary analysis dataset. During the surgery, a disposable intracerebral aspiration endoscope will be used to remove the intracerebral hematoma. Follow-ups will be conducted at discharge/Day 7 (±1 day), postoperative 1 month (±7 days), and postoperative 3 months (±15 days). Recording various indicators to evaluate the safety and effectiveness of the disposable intracerebral aspiration endoscope in treating intracerebral hematoma.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Endoscopic surgery
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic surgeryProcedure or surgery
Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic surgery | Experimental | Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma Receives: Procedure: Endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracerebral hematoma clearance rate
Perform a brain CT scan within 24 hours after surgery, comparing it with the baseline CT, and calculating the proportion of hematoma volume reduction.
Measured: Day 0（within 24 hours after procedure）
Secondary outcomes (7)
Hospitalization duration
Measured: During the days at hospital(up to 105 days)
Intensive Care Unit(ICU) duration
Measured: During the days at Intensive Care Unit(ICU)(up to 105 days)
The proportion of subjects with an mRS score of ≤3 at 3 months after surgery
Measured: 3 months after surgery(±15days)
The incidence of rebleeding at the surgical site within 7 days after surgery or before discharge.
Measured: 7 days (±1day) after surgery or before discharge.
The incidence of reoperation due to rebleeding at the surgical site during the follow-up period.
Measured: 3 months after surgery(±15days)
All-cause mortality
Measured: 3 months after surgery(±15days)
Device-related SAE
Measured: 3 months after surgery(±15days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start6 Feb 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843616
- Sponsor's protocol ID
- NeuroFlash-2024-01-CIP-00
- Status last verified
- Feb 2025
- First submitted
- 8 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）
- ClinicalTrials.gov ID
- NCT06843616
- Acronym / sponsor ID
- NeuroFlash-2024-01-CIP-00
- Conditions
- Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a prospective, open-label, single-arm clinical trial. According to the inclusion and exclusion criteria specified in the trial protocol, no fewer than 16 subjects with cerebral hemorrhage will be enrolled in 1 to 2 clinical centers. Considering the learning period required for doctor to become proficient in using the device, the first three cases at each research center are considered as the lead-in period cases and will not be included in the primary analysis dataset. During the surgery, a disposable intracerebral aspiration endoscope will be used to remove the intracerebral hematoma. Follow-ups will be conducted at discharge/Day 7 (±1 day), postoperative 1 month (±7 days), and postoperative 3 months (±15 days). Recording various indicators to evaluate the safety and effectiveness of the disposable intracerebral aspiration endoscope in treating intracerebral hematoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic surgery | Experimental | Procedure: Endoscopic surgeryUsing a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤ 80 years old;
- Spontaneous intracerebral hemorrhage;
- Hemorrhage located in the supratentorial subcortical or basal ganglia region;
- Hematoma volume ≥ 30ml and ≤ 80ml;
- Able to undergo surgery within 72 hours after onset;
Key exclusion criteria (17 listed)
- History of intracerebral hemorrhage within the past year;
- Traumatic intracerebral hemorrhage;
- Multiple intracerebral hemorrhages;
- Note: Hemorrhage in the supratentorial subcortical or basal ganglia region that extends into the ventricles is not considered multiple hemorrhages and can be included.
- Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic surgeryUsing a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma | Procedure or surgery | Endoscopic surgery |
Primary outcome
Intracerebral hematoma clearance rate
Time frame: Day 0（within 24 hours after procedure）
Perform a brain CT scan within 24 hours after surgery, comparing it with the baseline CT, and calculating the proportion of hematoma volume reduction.
7 secondary outcomes
Hospitalization duration
Time frame: During the days at hospital(up to 105 days)
Intensive Care Unit(ICU) duration
Time frame: During the days at Intensive Care Unit(ICU)(up to 105 days)
The proportion of subjects with an mRS score of ≤3 at 3 months after surgery
Time frame: 3 months after surgery(±15days)
The incidence of rebleeding at the surgical site within 7 days after surgery or before discharge.
Time frame: 7 days (±1day) after surgery or before discharge.
The incidence of reoperation due to rebleeding at the surgical site during the follow-up period.
Time frame: 3 months after surgery(±15days)
All-cause mortality
Time frame: 3 months after surgery(±15days)
Device-related SAE
Time frame: 3 months after surgery(±15days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic surgery in people with Intracerebral Hemorrhage, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huina Lu (021-38954600, HuiNa.Lu@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracerebral hematoma clearance rate (time frame: Day 0（within 24 hours after procedure）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.