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

Cancer, Lung Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03569111
Study type Observational
Source Medtronic - MITG
Contact
Status Completed
Phase
Start date February 27, 2019
Completion date October 28, 2020
View Details
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