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Transbronchial Lung Biopsy Guided by ENB

NCT03628222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2024-08-23

No results posted yet for this study

Summary

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

Conditions

  • Lung Lesion(s) Requiring Evaluation

Interventions

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.

Sponsors & Collaborators

  • Changzhou LungHealth Medtech Company Limited

    lead INDUSTRY

Principal Investigators

  • Shiyue Li · The First Affiliate Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2020-07-30
Completion
2020-08-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03628222 on ClinicalTrials.gov