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
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