A Feasibility Study on 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies: A Prospective, Multicenter, Single-Arm Clinical Study (BRIDGE Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Technical Success Rate (Lesion Level)
研究概览
简要总结
The purpose of the study is to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
详细描述
This is a prospective, multicenter, single-arm, and open-label clinical study. In this study, 15 patients will be enrolled to evaluate the technical feasibility of 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation for pulmonary malignancies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Pathologically confirmed non-small cell lung cancer, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤3; or metastatic lung tumors with the primary lesion well controlled, with a maximum tumor diameter ≤3 cm and the number of tumors requiring intervention is ≤
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤
- •Determined to be unsuitable for or unwilling to undergo surgery and radiotherapy.
- •Determined to be unsuitable for or unwilling to undergo antitumor drug therapy.
- •Considered technically feasible for robotic-assisted bronchoscopy-guided cryoablation of the target lesion(s).
- •Provided written informed consent after being fully informed of the study procedures, potential benefits, and risks.
排除标准
- •Unable to tolerate or unwilling to undergo general anesthesia.
- •Contraindications to bronchoscopy or unwillingness to undergo bronchoscopy.
- •Receipt of any form of local tumor therapy to the target lesion(s) within 6 months before the procedure.
- •Evidence of intrathoracic lymph node metastases or extrathoracic metastases within 1 month before the procedure, except for extrathoracic metastases that had been effectively controlled by local treatment.
- •Severe bleeding tendency or uncorrectable coagulation abnormalities, including a platelet count <50 × 10^9/L, prothrombin time >18 s, or prothrombin activity <40%.
- •Anticoagulant or antiplatelet therapy not discontinued for the required duration before the procedure.
- •Severe hepatic or renal dysfunction considered by the investigator to preclude participation in the study.
- •Uncontrolled infectious disease.
- •Severe concomitant pulmonary disease, including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis with emphysema, atelectasis, or pulmonary hypertension, considered by the investigator to preclude participation in the study.
- •Acute cardiovascular or cerebrovascular events, such as acute ischemic stroke or acute coronary syndrome, within 3 months before enrollment.
- •A history of severe cardiac dysfunction and/or severe cardiac arrhythmia.
- •Participation in another clinical trial involving treatment within the previous 3 months or concurrent participation in another clinical trial involving treatment.
- •Pregnancy or lactation, or plans to become pregnant during the study period;
- •Any other condition considered by the investigator to make the patient unsuitable for enrollment.
研究组 & 干预措施
Patients with pulmonary malignancies
15 patients with pulmonary malignancies who meet the inclusion and exclusion criteria will be prospectively enrolled. 5G-enabled remote robotic-assisted bronchoscopy-guided cryoablation will be performed to treat the lesions.
干预措施: 5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation (Procedure)
结局指标
主要结局
Technical Success Rate (Lesion Level)
时间窗: Immediately after procedure
The proportion of lesions achieving effective ablation under 5G-enabled remote robotic-assisted bronchoscopy guidance among all lesions that undergo ablation. Effective ablation is defined as an immediate post-procedural imaging finding demonstrating an ablation zone extending at least 5 mm beyond the margin of the target lesion.
次要结局
- Complete Ablation Rate at 6 Months (Lesion Level)(6 months)
- Complete Ablation Rate at 12 Months (Lesion Level)(12 months)
- Intrapulmonary Progression-Free Survival Rate at 6 Months (Patient Level)(6 months)
- Intrapulmonary Progression-Free Survival Rate at 12 Months (Patient Level)(12 months)
- Overall Survival Rate at 12 Months (Patient Level)(12 months)
- Remote Image Transmission Latency(Immediately after procedure)
- Remote Control Latency(Immediately after procedure)
- Packet Loss Rate(Immediately after procedure)
- Safety (Patient Level)(1 month)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital