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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMicroPort NeuroTech Co., Ltd.

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 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.

Eligibility criteria

Qualifiers

Age ≥ 18 and ≤ 80 years old;

Spontaneous intracerebral hemorrhage;

Hemorrhage located in the supratentorial subcortical or basal ganglia region;

Hematoma volume ≥ 30ml and ≤ 80ml;

Disqualifiers

History of intracerebral hemorrhage within the past year;

Traumatic intracerebral hemorrhage;

Multiple intracerebral hemorrhages;

Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;

Trial design

Treatments tested in this trial

  • Endoscopic surgery

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators