NCT03628222

Transbronchial Lung Biopsy Guided by ENB

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Changzhou LungHealth Medtech Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Lung Lesion(s) Requiring Evaluation

Interventions

Type	Name	Description
DEVICE	ENB-TBLB	ENB Guidance: The iLungTM SuperNavigator system will be used, it comprises of iLungTM ENB system, location catheter and guide catheter. The guide catheter can supply a 1.9 mm working channel for biopsy tools. The location catheter is inserted into the guide catheter beforehand, then both are introduced via the working channel of the bronchoscope. Under guidance of ENB system, the location catheter reaches the lesion, and actual distance is confirmed by the X-ray. TBLB: Location catheter is retracted, then the biopsy forceps and brush was introduced, and pathologic specimens are obtained.
DEVICE	X-ray-TBLB	Based on chest CT, the physician determines the lesion location. Under X-ray guidance, via the bronchoscope's working channel, the biopsy forceps and brush are introduced and pathologic specimens are obtained.

Timeline

• Start date: 2019-01-04
• Primary completion: 2020-07-30
• Completion: 2020-08-10
• First posted: 2018-08-14
• Last updated: 2024-08-23

Locations

8 sites across 1 country: China