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.
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