Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
研究概览
简要总结
The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use.
This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. The study is designed to characterize the safety and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology.
详细描述
The primary objective of this prospective, single-arm, multicenter, non-randomized study is to characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in subjects undergoing lung ablation procedures.
The primary endpoint is the composite rate of adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
The following secondary endpoints will be evaluated:
- Composite rate of serious adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
- Composite rate of all adverse events related to the procedure or study devices through 1-month follow-up.
- Composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up.
- Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
- Quality of life (EQ-5D Scale)
- Technical success
- Technique efficacy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is ≥ 18 years of age
- •Subject has provided informed consent
- •Subject is able and willing to comply with the study follow-up schedule
- •Subject has a definitive diagnosis of cancer in the lung
- •Target nodule is ≤ 30mm in maximum diameter
- •There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure
- •Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure
- •Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use
- •Subject is not a candidate for lung surgery or refuses lung surgery
- •Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT
排除标准
- •Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
- •Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
- •Female subjects who are pregnant or nursing as determined by standard site practices
- •Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- •The investigator determines that participation in the study may jeopardize the safety or welfare of the subject
结局指标
主要结局
Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
时间窗: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
The primary endpoint is the rate of adverse events (AEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
次要结局
- Number of Participants With SAEs Related to the Study Procedure or Study Devices(During procedure through 1-month follow-up (an average of 20-40 days post-procedure))
- Score of Patient Satisfaction, Pain, and Breathlessness(Immediately following the procedure, 1 week post-procedure, 1-month post-procedure; all were collected at the 1-month follow-up visit (20-40 days post-procedure))
- Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol(Immediately post-procedure)
- Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology(During procedure through 1-month follow-up (an average of 20-40 days post-procedure))
- Score of Current Health State From Quality of Life Survey(Baseline and 1-month)
- Number of Lung Nodules Evaluated as Being Effectively Ablated(1-month follow-up (an average of 20-40 days post-procedure))
- Number of Participants With AEs Related to Study Procedure or Study Devices(During procedure through 1-month follow-up (an average of 20-40 days post-procedure))