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

Completed

Conditions: Cancer, Metastatic to Lung
Cancer, Lung

Registration Number: NCT03569111

Lead Sponsor: Medtronic - MITG

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With AEs 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)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Rate of all SAEs related to the procedure or study devices through 1-month follow-up.
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)	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).
Number of Lung Nodules Evaluated as Being Treated According to the Study Protocol	Immediately post-procedure	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.
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)	Rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
Score of Current Health State From Quality of Life Survey	Baseline and 1-month	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).
Number of Lung Nodules Evaluated as Being Effectively Ablated	1-month follow-up (an average of 20-40 days post-procedure)	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).
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)	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.