NCT06832943尚未招募不适用
A Prospective Multicenter Single-Arm Trial Evaluating the Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis
Guangzhou Medical University0 个研究点目标入组 30 人开始时间: 2025年2月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The success rate of stent placement
研究概览
简要总结
The primary aim of this research is to assess the efficacy and safety of the bronchial navigation positioning equipment in assisting stent implantation for malignant central airway stenosis while guaranteeing the safety of the participants and the scientificity of the clinical trial.
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
- •Patients are eligible only if they fulfill all of the following criteria:
- •Age ≥ 18 years, regardless of gender;
- •Patients voluntarily consent to airway stent implantation and meet the requirements for airway stent implantation under general anesthesia;
- •Confirmed as having malignant central airway stenosis through bronchoscopy and being ineligible for surgery or refusing surgery, and in need of airway stent implantation.
- •Patients should be able to understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.
排除标准
- •Patients fulfilling any of the following criteria will be excluded from this study:
- •Severe dysfunction of the heart, lungs, liver, or kidneys, intolerant of bronchoscopic treatment;
- •Apparent coagulation dysfunctions;
- •Pregnant or lactating women, or participants with a pregnancy plan during the study period;
- •Patients with implanted cardiac pacemakers, implanted defibrillators, or other active implants;
- •Participants allergic to photosensitizers or anesthetics, or with a history of multiple severe allergies or hereditary allergies;
- •Participants who have participated in or are currently participating in drug clinical trials within the past 3 months, or in other medical device clinical trials within the past 30 days; Other circumstances that the investigator considers inappropriate for participation in this clinical trial.
结局指标
主要结局
The success rate of stent placement
时间窗: During the bronchoscopy
The success rate of stent placement = (The number of patients with successful stent placement / The number of patients undergoing stent placement surgery) × 100% Successful placement: The stent is placed in the appropriate position without displacement, and the upper and lower ends of the stent are unobstructed.
次要结局
未报告次要终点
研究者
Li Shiyue
Professor
Guangzhou Medical University
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