The purpose of this study is to evaluate the performance and safety of electromagnetic navigation bronchoscopy (ENB) system and system kit (iLungTM SuperNavigator) .
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB
Timeframe: Up to 6 months
Trial details
NCT IDNCT03628222
SponsorChangzhou LungHealth Medtech Company Limited