Transbronchial Lung Biopsy Guided by ENB

Lung Lesion(s) Requiring Evaluation Clinical Trial

Official title: Transbronchial Lung Biopsy Guided by Electromagnetic Navigation Bronchoscopy: A Prospective, Randomized, Multicenter, Superiority Study

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the performance and safety of electromagnetic navigation bronchoscopy (ENB) system and system kit (iLungTM SuperNavigator) .

Clinical Trial Description

This is prospective, randomized, multicenter, superiority study. 8 top centers in China was chosen. Subject which has peripheral lung lesions (PLLs) detected by chest CT scan, requires biopsy diagnosis, and meets all inclusion and exclusion criteria, will be included in this trial. Firstly physician determines the lesion biopsied, then the subject will be randomized to experimental or control group. The experimental group is treated with ENB guided transbronchial lung biopsy (TBLB)(ENB-TBLB): Under ENB guidance, the location sensor reaches the edge of the lesion, and X-ray is used for actual distance confirmation, if physician determines the distance is enough for biopsy, TBLB will be conducted. The control group will be treated with TBLB using X-ray guidance. ;

Related Conditions & MeSH terms

• Lung Lesion(s) Requiring Evaluation

• NCT number: NCT03628222
• Study type: Interventional
• Source: Changzhou LungHealth Medtech Company Limited
• Contact: Shiyue Li
• Phone: +8613902233925
• Email: lishiyue@188.com
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2019
• Completion date: June 2020