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.
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
Study Type
OBSERVATIONAL
Enrollment
30
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.
Prince of Wales Hospital
Hong Kong, Hong Kong
St. Bartholomew's Hospital
London, United Kingdom
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.
Time frame: During procedure through 1-month follow-up (an average of 20-40 days post-procedure)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 1-month follow-up (an average of 20-40 days post-procedure)