A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The primary safety endpoint for this study is patient safety
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and general safety in the human airway as well as assess the safety and depth and area of treatment using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) using surgical resection specimens from patients undergoing lobectomy.
详细描述
The primary endpoints for this study are patient safety and the histological effects of cryospray therapy in lobectomy patients.
The proposed study is a single center study to evaluate the safety and treatment effect of sprayed liquid nitrogen through a catheter via FFB using surgical resection specimens from patients undergoing lobectomy.
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 of age
- •Lobectomy planned based on clinical situation not related to this study.
- •Deemed operable based on institutional criteria.
排除标准
- •Pregnant or nursing
- •Planning to sire a child while enrolled in the study
- •Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
- •Refusal or inability to give consent.
- •Concurrent chemotherapy.
- •Prior radiation therapy which involved the lungs
- •Medical contraindication or potential problem that would preclude study participation
- •Concurrent participation in other experimental studies
- •Uncontrolled coagulopathy or bleeding diathesis
- •Serious medical illness, including:
- •Uncontrolled congestive heart failure
- •Uncontrolled angina
- •Myocardial infarction
- •Cerebrovascular accident within 6 months prior to study entry
结局指标
主要结局
The primary safety endpoint for this study is patient safety
时间窗: Throughout study
The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients
时间窗: Throughout Study
次要结局
未报告次要终点