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RECRUITING
NCT06843616
NA

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

Sponsor: MicroPort NeuroTech Co., Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-02-06

Completion Date

2025-10-31

Last Updated

2025-02-25

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic surgery

Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma

Locations (1)

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China