Transbronchial Lung Biopsy Guided by ENB

Changzhou LungHealth Medtech Company

Status: Completed

Conditions: Lung Lesion(s) Requiring Evaluation

Treatments: Device: X-ray-TBLB; Device: ENB-TBLB

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628222

LHCTP001

Details and patient eligibility

About

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

Full 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.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

ENB-TBLB

Experimental group

Description:

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.

Treatment:

Device: ENB-TBLB

X-ray-TBLB

Active Comparator group

Description:

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.

Treatment:

Device: X-ray-TBLB