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

Recruiting N/A Interventional Study
Intracerebral Hemorrhage
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
16 (estimated)
Sponsor
MicroPort NeuroTech Co., Ltd. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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…
Contacts

Huina Lu

021-38954600

HuiNa.Lu@microport.com

CONTACT