NCT05967091进行中（未招募）不适用
Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study
Ryme Medical, Inc.7 个研究点 分布在 6 个国家目标入组 60 人开始时间: 2024年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Device Safety
研究概览
简要总结
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study
详细描述
The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic chronic obstructive pulmonary disease
- •≥40 years of age
- •Smoking history of at least 10 pack years
- •Candidate for bronchoscopy in the opinion of the Investigator
排除标准
- •Recent COPD exacerbation or respiratory infection
- •Prior lung intervention with device in place
- •Pulmonary nodule or malignancy requiring treatment
- •Current chemotherapy or radiation therapy and/or has received treatment within 6 months
- •Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not prescribed by a physician
- •Clinically significant serious or unstable medical conditions (e.g., heart disease requiring treatment, uncontrolled diabetes)
- •Pregnant, nursing, or intent to become pregnant during study duration
结局指标
主要结局
Device Safety
时间窗: 30 Days
Serious adverse events associated with the Ryme Medical Lung Denervation System
次要结局
- Technical Success(Day 0)
- Device Success(Day 0)
研究者
研究点 (7)
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