Transbronchial Lung Biopsy Guided by ENB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2020-08-10

Brief Summary

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

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Detailed Description

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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

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Lung Lesion(s) Requiring Evaluation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ENB-TBLB

Under ENB guidance, the Location Catheter and Guide Catheter reach the lesion. After confirmation by X-ray, biopsy tools are introduced and specimens are obtained.

Group Type EXPERIMENTAL

ENB-TBLB

Intervention Type DEVICE

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-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 specimens are obtained.

Group Type ACTIVE_COMPARATOR

X-ray-TBLB

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years and older;
* Subject presents with PLL(s) detected by chest CT scan and biopsy diagnosis is needed;
* Subject is willing to receive bronchoscopy voluntarily, and meets relevant requirements;
* Subject or their guardian understands the purpose of this trial, and willing to participate in the trial voluntarily and sign Informed Consent Form (ICF).

Exclusion Criteria

* Subject has participated in a drug or device study (drug study within 3 months or device study within 1 month);
* Female subject who is pregnant or nursing;
* Allergic to anesthetic;
* Bronchoscopy contraindications, include: Active hemoptysis; Newly developed myocardial infarction or unstable angina attack; Severe cardiac and pulmonary dysfunction; Severe hypertension and arrhythmia; Uncorrectable bleeding tendency (Such as severe clotting dysfunction, uremia, and severe pulmonary hypertension, etc.); Severe superior vena cava obstructive syndrome; Suspected aortic aneurysm; Multiple lung bullae; Extremely exhausted systemic conditions;
* Subject with serious lung disease (Such as: severe bronchiectasis, severe emphysema, etc) ,which investigator considers not appropriate for this examination;
* Subject with implanted pacemaker or defibrillator;
* Lack of patient cooperation for bronchoscopy, such as patient with mental disorders, dysgnosia, psychological disorder etc;
* Conditions investigator considers not appropriate for this trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No