A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Intracerebral hematoma clearance rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Endoscopic surgery
Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma
干预措施: Endoscopic surgery (Procedure)
结局指标
主要结局
Intracerebral hematoma clearance rate
时间窗: Day 0（within 24 hours after procedure）
Perform a brain CT scan within 24 hours after surgery, comparing it with the baseline CT, and calculating the proportion of hematoma volume reduction.
次要结局
- The incidence of reoperation due to rebleeding at the surgical site during the follow-up period.(3 months after surgery(±15days))
- All-cause mortality(3 months after surgery(±15days))
- Device-related SAE(3 months after surgery(±15days))
- The proportion of subjects with an mRS score of ≤3 at 3 months after surgery(3 months after surgery(±15days))
- The incidence of rebleeding at the surgical site within 7 days after surgery or before discharge.(7 days (±1day) after surgery or before discharge.)
- Hospitalization duration(During the days at hospital(up to 105 days))
- Intensive Care Unit(ICU) duration(During the days at Intensive Care Unit(ICU)(up to 105 days))