A Clinical Application Study of a CT Guided Small Pulmonary Nodule Puncture and Positioning Device Based on Pre-filled Absorbable Semi-barbed Wire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
Hookwire and microcoil are currently the most widely used localization instruments. Although their success rate is relatively high in preoperative localization attempts, they may lead to consequences that negatively affect patient outcomes, such as pain because of the metal's hardness, localization failure due to wire detachment, and the presence of permanent traces of metal and foreign bodies .
To overcome these disadvantages, we designed an absorbable semi-barbed suture to localize small intrapulmonary nodules (patent number: ZL201821444387.X).
The results of the previous animal experiments were satisfactory, and it is now necessary to recruit 10 patients for clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •solid nodules with a diameter2cm and distance to visceral pleura 0.5cm；
- •part-solid GGN, with a solid portion1cm and distance to the visceral pleura 1cm；
- •Patients with nodules at a deep location, who underwent localization to facilitate localization in the resected specimen by a pathologist
排除标准
- •The lesion site is not suitable for percutaneous lung puncture;
- •those who have pneumothorax and pleural effusion;
- •Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;
- •Those who refuse surgery;
- •Those who did not sign the informed consent form.
研究组 & 干预措施
Semi-barbed Sutures Localization Group
Patients with pulmonary nodules requiring CT-guided puncture positioning before thoracoscopic surgery
干预措施: absorbable semi-barbed suture (Device)
结局指标
主要结局
Success rate
时间窗: half an hour after locating
Successfully located around the small nodules in the lungs, no dislocation occurred
次要结局
未报告次要终点