A Prospective, Global, Multicenter, Randomized, Double Blind, Sham Controlled Study to EValuate the Safety and effectIVEness of the Ryme Medical Targeted Lung Denervation (TLD) Catheter in Patients With Moderate and Severe Symptomatic Chronic Obstructive Pulmonary Disease (COPD) - The REVIVE Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- COPD Assessment Test (CAT)
研究概览
简要总结
The goal of this study is to test whether a new treatment called the Ryme Medical Targeted Lung Denervation (TLD) Catheter is safe and effective for people with moderate to severe chronic obstructive pulmonary disease (COPD).
The main questions it aims to answer are:
- Does the TLD Catheter improve symptoms in people with COPD?
- Is the TLD Catheter safe ?
Researchers will compare the group receiving the TLD treatment to the group receiving a sham procedure to see if the treatment improves quality of life.
Participants will:
- Be randomly assigned to receive either the TLD treatment or a sham procedure.
- Undergo the assigned procedure in a hospital setting.
- Attend follow-up visits for health checks and breathing tests.
详细描述
This study is a prospective, global, multicenter, randomized, double blind, sham controlled study to evaluate the safety and effectiveness of the Ryme Medical Targeted Lung Denervation (TLD) Catheter compared to sham in patients with moderate and severe symptomatic chronic obstructive pulmonary disease (COPD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic chronic obstructive pulmonary disease
- •History of COPD exacerbation(s)
- •Stable medical therapy
- •Candidate for bronchoscopy
排除标准
- •Prior lung intervention with device in place
- •Using tobacco products, e-cigarettes, vape or other inhaled non-pharmacological substance
- •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
研究组 & 干预措施
Ryme Targeted Lung Denervation (TLD) Procedure
Ryme TLD Procedure
干预措施: Ryme TLD (Device)
Sham Control Procedure
Sham Control Procedure
干预措施: Sham Control (Device)
结局指标
主要结局
COPD Assessment Test (CAT)
时间窗: 12 months
Change from baseline
次要结局
- St. George Respiratory Questionnaire (SGRQ) Total Score(12 months)
- Six Minute Walk Test (6MWT)(12 months)
- COPD exacerbations(12 months)