ClinicalTrials.gg
RecruitingNCT06843616Updated Feb 25, 2025

A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA(FAST-HET)

An interventional study of Endoscopic surgery in Intracerebral Hemorrhage, sponsored by MicroPort NeuroTech Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by MicroPort NeuroTech Co., Ltd. (formerly part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 122 studies in Cerebral Hemorrhage with a site in China — 58 open to participants now, 61 under way, 5 of them phase 3. Cerebral Hemorrhage · China.

Planned enrollment
73rd of 77
16 · median 180
Started
2025
with 19 others
No phase
35 of 122
22 open now
Primary completion
2025-08
later than 12 of 60 live
Registered
90th of 122
by date

Among the 122 studies in Cerebral Hemorrhage with a site in China, this one is the 73rd largest by planned enrollment of the 77 interventional ones that give a count, is one of 20 that started in 2025, is one of 35 with no phase, reaches primary completion later than 12 of the 60 other live ones, and was the 90th registered.

Cerebral Hemorrhage

457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.

Browse Cerebral Hemorrhage studies →

Open to participants now

58 of the 122 studies in Cerebral Hemorrhage with a site in China are open now. Recruiting first, the newest first:

52 more — sign in →

All 58 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 112 Cerebral Hemorrhage studies recruiting now, 58 (52%) set no upper age limit and 9 (8%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 122 studies in Cerebral Hemorrhage with a site in China, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Intracerebral Hemorrhage

Browse trials for

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 and ≤ 80 years old;
  2. Spontaneous intracerebral hemorrhage;
  3. Hemorrhage located in the supratentorial subcortical or basal ganglia region;
  4. Hematoma volume ≥ 30ml and ≤ 80ml;
  5. Able to undergo surgery within 72 hours after onset;
  6. GCS score of 5 to 14;
  7. The subject themselves and/or their authorized representative can understand the purpose of the study, agree to participate, and sign the form.

Exclusion criteria

Exclusion Criteria:

  1. History of intracerebral hemorrhage within the past year;
  2. Traumatic intracerebral hemorrhage;
  3. 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.

  4. Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
  5. Formation of brain herniation;
  6. Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);
  7. mRS score ≥ 3 before onset;
  8. 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;
  9. count less than 100 × 10\^3/μL or (INR) greater than 1.4;
  10. Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;
  11. Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg after medication upon admission);
  12. Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;
  13. Women of childbearing age who are pregnant or breastfeeding;
  14. Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;
  15. ≤ 1 year;
  16. Other situations where the researcher deems the subject unsuitable for the study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Endoscopic surgery

    Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma

    Procedure: Endoscopic surgery

Interventions

  • ProcedureEndoscopic surgery

    Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0(within 24 hours after procedure)

Secondary outcomes

  1. Hospitalization duration

    Time frame: During the days at hospital(up to 105 days)

  2. Intensive Care Unit(ICU) duration

    Time frame: During the days at Intensive Care Unit(ICU)(up to 105 days)

  3. The proportion of subjects with an mRS score of ≤3 at 3 months after surgery

    Time frame: 3 months after surgery(±15days)

  4. 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.

  5. The incidence of reoperation due to rebleeding at the surgical site during the follow-up period.

    Time frame: 3 months after surgery(±15days)

  6. All-cause mortality

    Time frame: 3 months after surgery(±15days)

  7. Device-related SAE

    Time frame: 3 months after surgery(±15days)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Aug 2025, 6 months after the start.

Of 84 interventional studies with no phase under Cerebral Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 72. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2025
First posted
Feb 25, 2025
StartActual
Feb 6, 2025
Primary completionEst.
Aug 31, 2025
CompletionEst.
Oct 31, 2025
Last update
Feb 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06843616
Responsible party
Sponsor
First posted
Feb 25, 2025
Start date
Feb 6, 2025
Primary completion
Aug 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Feb 25, 2025

Study contacts

Huina Lu
Contact
HuiNa.Lu@microport.com
021-38954600

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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