NCT06843616

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: MicroPort NeuroTech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Endoscopic surgery	Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma

Timeline

• Start date: 2025-02-06
• Primary completion: 2025-08-31
• Completion: 2025-10-31
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: China