NCT05807022Unknown不适用
Evaluation of the Safety and Effectiveness of Percutaneous and Transbronchial Argon-helium Cryoablation
China-Japan Friendship Hospital0 个研究点目标入组 60 人开始时间: 2023年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Complete response rate and effective rate of target lesions
研究概览
简要总结
The goal clinical trial is to evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation in primary lung cancer and metastatic lung cancer. The main question it aims to answer are:Evaluation of the safety and effectiveness of percutaneous and transbronchial argon-helium cryoablation.
Participants will undergo percutaneous or transbronchial argon-helium cryoablation.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or metastatic lung cancer with definite pathological diagnosis
- •Not suitable for thoracotomy due to serious or serious lung or systemic diseases
- •Peripheral lung cancer involves pleura and chest wall, and cannot be completely removed after surgery
- •There are indications for surgical resection, but the patient refuses to operate
- •Single tumor, maximum diameter ≤ 5cm
- •Or the number of tumors ≤ 3 and the maximum diameter ≤ 3cm
- •ECOG-PS score ≤ 2
- •The expected survival period is more than three months
- •Those who have not participated in other clinical verifications within 3 months
- •Subjects voluntarily signed the informed consent form
排除标准
- •Serious cardio-cerebral disease or other mental diseases
- •Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis
- •Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder and multiple pulmonary bullae
- •Have a history of immunodeficiency, including HIV test (enzyme-linked immunosorbent assay and Western blotting) positive
- •Chemotherapy, radiotherapy, interventional therapy, ablation and surgical treatment within 30 days before surgical treatment
- •There is a tendency to severe bleeding, and the platelet is less than 50 × 109/L and severe disorder of coagulation function
- •Coagulation index (PT, TT, APTT)>2.5 times of the upper normal limit
- •Malignant pleural effusion on the same side of the ablation focus was not well controlled
- •Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorder
- •Those who have extensive extrapulmonary metastasis and are not suitable for ablation treatment
- •Those who often use sedatives, sleeping pills, tranquilizers or other addictive drugs
- •Pregnant or lactating women
- •Those who can not judge the curative effect
- •Other conditions determined by the researcher to be unsuitable for the group, such as inability to tolerate cryoablation, difficulty in follow-up, and other serious diseases
结局指标
主要结局
Complete response rate and effective rate of target lesions
时间窗: 4 weeks(±7d) after the operation of argon-helium cryoablation
Enhanced imaging examination (CT, MRI or color Doppler ultrasound)
次要结局
- Subjects' tolerance of the procedure(1 week after the operation of argon-helium cryoablation)
- To evaluate the operational performance of argon-helium cryoablation(during the procedure)
- the iceball coverage rate during the procedure(during the procedure)
- the Eastern Cooperative Oncology Group Performance Status (ECOG PS) score(4 weeks(±7d) after the operation of argon-helium cryoablation)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital
相似试验
招募中
3 期
Effectiveness and Safety of TENS Therapy for Premature EjaculationSex DisorderTENPremature EjaculationNCT06425224Boston Medical Group129
进行中（未招募）
不适用
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure SystemAtrial FibrillationNCT04807283Laminar, Inc.29
尚未招募
不适用
Phitys I™ Percutaneous Left Ventricular Assist System StudyCoronary Artery DiseaseNCT06357026Shanghai NewMed Medical Co., Ltd.344
尚未招募
不适用
Phimume® Percutaneous Left Ventricular Assist System StudyCoronary Artery DiseaseNCT06639321Shanghai NewMed Medical Co., Ltd.250
招募中
不适用
Valveclip® Transcatheter Mitral Valve Repair StudyMitral RegurgitationNCT05021614Shanghai NewMed Medical Co., Ltd.150