A Prospective, Multicenter, Single Group Clinical Study to Evaluate the Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Positioning success rate
研究概览
简要总结
During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure.
The aim of this study is to evaluate the efficacy and safety of using disposable pulmonary surgical markers to localize pulmonary nodules in subjects prior to the resection of pulmonary nodules by video-assisted thoracoscopic surgery (VATS).
详细描述
It is a prospective, multicenter, single group target value clinical trial. The subjects will undergo VATS within 24h after the placement of the Marker, then the Marker and targeted nodule will be removed during VATS. Subjects will be followed up intraoperatively, immediately after placement procedure to the end of VATS resection, 7 days after placement procedure/before discharge (whichever occurs earlier), and 30 days after Marker placement procedure. Demographic and baseline information of subjects, immediate operation success rate of marker placement, positioning success rate, and adverse events will be collected and recorded in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old；
- •Pulmonary nodule, which satisfying any of the following Criteria:
- •solid nodules with diameter ≤1 cm or solid component ≤1 cm non-purely ground glass, and the distance between the solid component of the nodule and the visceral pleural>0.5cm;
- •Pure ground glass opacity (pGGO)；
- •Before VATS operation, the doctor judge that the nodule is difficult to locate during the operation.
- •Pulmonary wedge resection or Segmental pulmonary resection under VATS is proposed;
- •Preoperative evaluation shows that placing marker through bronchus is feasible；
- •The subject is able to fully understand the requirements of clinical research;
- •Subject or the legal representative signs the informed consent form.
排除标准
- •Contraindications for bronchoscopy;
- •Systemic factors: sepsis, history of repeated pulmonary infections, and any type of severe infectious disease within one month of screening；
- •Severe cardio and pulmonary disease；
- •Coagulation dysfunction, with a clear tendency to bleed;
- •General anesthesia contraindication;
- •Allergic history of nickel-titanium materials;
- •Breast-feeding or may be or plan to be pregnant during the trial;
- •Participating in clinical trials of other drugs or medical devices;
- •Other conditions that Investigator consider the subject to be inappropriate.
结局指标
主要结局
Positioning success rate
时间窗: Immediately after VATS
The proportion of patients who complete VATS resection of target pulmonary nodules/number of patients receiving localization of target pulmonary nodules before operation, expressed as "rate", will be evaluated during and immediately after surgery to evaluate the effectiveness of disposable pulmonary surgical markers in the localization of pulmonary nodules in surgery.
次要结局
- Positioning success rate (in terms of marker placement)(Immediately after VATS)
- Operation time of exploration and removal of target lesion during VATS (in terms of marker placement)(Immediately after VATS)
- Immediate operation success rate of marker placement (in terms of marker, placement),including the following operations:(Immediately after marker placement)
- Operation time of Marker placement (in terms of marker placement)(Immediately after marker placement)
- Operation time of marker release through bronchoscopy (in terms of marker placement)(Immediately after marker placement)
- Safety: AEs (Adverse Events) and SAEs (Serious Adverse Events) occured during the clinical trial(30days)