NCT03569111

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cancer, Lung
• Cancer, Metastatic to Lung

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-27
• Primary completion: 2020-10-28
• Completion: 2020-10-28
• First posted: 2018-06-26
• Last updated: 2022-11-15
• Results posted: 2022-11-15

Locations

2 sites across 2 countries: Hong Kong, United Kingdom