CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 226 enrolled
Drug / intervention
ENB-TBLB +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03628222
NCT03628222N/ACompleted
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Transbronchial Lung Biopsy Guided by Electromagnetic Navigation Bronchoscopy: A Prospective, Randomized, Multicenter, Superiority Study

Changzhou LungHealth Medtech Company Limited·interventional·Posted Aug 14, 2018·Updated Aug 23, 2024

In Brief

A clinical study evaluating ENB-TBLB and X-ray-TBLB for Lung Lesion(s) Requiring Evaluation. Completed, enrolled 226 participants across 8 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Lesion(s) Requiring Evaluation
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartJan 4, 2019
Primary CompletionJul 30, 2020
Study CompletionAug 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.9 years ago

Interventions

ENB-TBLBdevice

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.

X-ray-TBLBdevice

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.