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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Affiliated Hospital of Guizhou Medical University — Guiyang

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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