Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology

Conditions
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Cancer, Lung, Cancer, Metastatic to Lung

Intervention / Treatment
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* Device: Bronchoscopic ablation catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bronchoscopic ablation catheter|The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is deployed endoscopically and will be used to conduct bronchoscopic ablations in the lung using the superDimension™ navigation system.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With AEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | 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. | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With SAEs Related to the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology | Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up. | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) | 
| Number of Participants With AEs Related to Study Procedure or Study Devices | Rate of all AEs related to the procedure or study devices through 1-month follow-up. Rate of all AEs related to the procedure or study devices through 1-month follow-up was also measured based on Common Terminology Criteria for Adverse Events (CTCAE) classification. CTCAE grading is evaluated on a scale from 1-5 (1 - mild; intervention not indicated; 5 - most severe; death related to AE). Subjects could have more than one AE with different CTCAE Grades. | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) | 
| Number of Participants With SAEs Related to the Study Procedure or Study Devices | Rate of all SAEs related to the procedure or study devices through 1-month follow-up. | During procedure through 1-month follow-up (an average of 20-40 days post-procedure) | 
| Score of Patient Satisfaction, Pain, and Breathlessness | Patient satisfaction, pain, and breathlessness (Bronchoscopic Ablation Patient Pain and Satisfaction Survey) At the 1-month visit, subjects assessed their pain/discomfort and breathlessness based on how they recall feeling at 3 different timepoints. The timepoints were immediately, one week, and one month after the bronchoscopic ablation procedure. Pain or discomfort were evaluated on a scale from 0-10 (10 - severe/interferes with basic needs). Breathlessness was evaluated on a scale from 1-5 (5 - too breathless to leave the house, or breathless when undressing). Subjects also evaluated their willingness to have the procedure performed again on a scale from 1-5 (5 - extremely likely), how likely they would recommend the procedure to family and friends on a scale from 1-5 (5 - extremely likely), and how satisfied they were with the procedure on a scale from 1-5 (5 - extremely satisfied). | 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) | 
| Score of Current Health State From Quality of Life Survey | Quality of life evaluation based on EuroQol [EQ-5D-3L] survey. The questions from the survey surround current health status. The subjects assessed their current health state on a scale of 0-100 (100 being the best health state imaginable). | Baseline and 1-month | 
| Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol | Technical success: An evaluation of whether the lung nodule was treated according to the study protocol as determined at the immediate post-procedural timepoint. This is in contrast to procedures in which the protocol could not be executed completely, either for technical reasons or for reasons related to comorbid disease. | Immediately post-procedure | 
| Number of Lung Nodules Evaluated as Being Effectively Ablated | Technique efficacy: An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation of the nodule was achieved as evidenced by CT imaging follow-up 1-month post-procedure (including a window of 20-40 days post-procedure). | 1-month follow-up (an average of 20-40 days post-procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Nodule, Bronchoscopy, Ablation, Microwave