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

Overview

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.

Interventions

• Procedure Endoscopic surgery
  Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma

Primary outcome measures

• Intracerebral hematoma clearance rate [Time frame: Day 0（within 24 hours after procedure）]

Secondary outcome measures (7)

• Hospitalization duration [Time frame: During the days at hospital(up to 105 days)]
• Intensive Care Unit(ICU) duration [Time frame: During the days at Intensive Care Unit(ICU)(up to 105 days)]
• The proportion of subjects with an mRS score of ≤3 at 3 months after surgery [Time frame: 3 months after surgery(±15days)]
• The incidence of rebleeding at the surgical site within 7 days after surgery or before discharge. [Time frame: 7 days (±1day) after surgery or before discharge.]
• The incidence of reoperation due to rebleeding at the surgical site during the follow-up period. [Time frame: 3 months after surgery(±15days)]
• All-cause mortality [Time frame: 3 months after surgery(±15days)]
• Device-related SAE [Time frame: 3 months after surgery(±15days)]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 and ≤ 80 years old;
• Spontaneous intracerebral hemorrhage;
• Hemorrhage located in the supratentorial subcortical or basal ganglia region;
• Hematoma volume ≥ 30ml and ≤ 80ml;
• Able to undergo surgery within 72 hours after onset;
• GCS score of 5 to 14;
• The subject themselves and/or their authorized representative can understand the purpose of the study, agree to participate, and sign the informed consent form.

Exclusion criteria

• History of intracerebral hemorrhage within the past year;
• Traumatic intracerebral hemorrhage;
• Multiple intracerebral hemorrhages;

Note: Hemorrhage in the supratentorial subcortical or basal ganglia region that extends into the ventricles is not considered multiple hemorrhages and can be included.

• Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
• Formation of brain herniation;
• Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);
• mRS score ≥ 3 before onset;
• Use of anticoagulants or antiplatelet drugs within 14 days before onset, or the need for long-term use of anticoagulants or antiplatelet drugs, or other factors causing coagulation dysfunction;
• Platelet count less than 100 × 10\^3/μL or international normalized ratio (INR) greater than 1.4;
• Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;
• Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg after medication upon admission);
• Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;
• Women of childbearing age who are pregnant or breastfeeding;
• Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;
• Life expectancy ≤ 1 year;
• Other situations where the researcher deems the subject unsuitable for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Affiliated Hospital of Guizhou Medical University — Guiyang

Identifiers

NCT: NCT06843616 · NeuroFlash-2024-01-CIP-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗