Transbronchial Lung Biopsy Guided by ENB

Not Applicable

Completed

• Conditions: Lung Lesion(s) Requiring Evaluation

• Registration Number: NCT03628222
• Lead Sponsor: Changzhou LungHealth Medtech Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-7-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 years and older;<br><br> - Subject presents with PLL(s) detected by chest CT scan and biopsy diagnosis is<br> needed;<br><br> - Subject is willing to receive bronchoscopy voluntarily, and meets relevant<br> requirements;<br><br> - Subject or their guardian understands the purpose of this trial, and willing to<br> participate in the trial voluntarily and sign Informed Consent Form (ICF).<br><br>Exclusion Criteria:<br><br> - Subject has participated in a drug or device study (drug study within 3 months or<br> device study within 1 month);<br><br> - Female subject who is pregnant or nursing;<br><br> - Allergic to anesthetic;<br><br> - Bronchoscopy contraindications, include: Active hemoptysis; Newly developed<br> myocardial infarction or unstable angina attack; Severe cardiac and pulmonary<br> dysfunction; Severe hypertension and arrhythmia; Uncorrectable bleeding tendency<br> (Such as severe clotting dysfunction, uremia, and severe pulmonary hypertension,<br> etc.); Severe superior vena cava obstructive syndrome; Suspected aortic aneurysm;<br> Multiple lung bullae; Extremely exhausted systemic conditions;<br><br> - Subject with serious lung disease (Such as: severe bronchiectasis, severe emphysema,<br> etc) ,which investigator considers not appropriate for this examination;<br><br> - Subject with implanted pacemaker or defibrillator;<br><br> - Lack of patient cooperation for bronchoscopy, such as patient with mental disorders,<br> dysgnosia, psychological disorder etc;<br><br> - Conditions investigator considers not appropriate for this trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB

Secondary Outcome Measures

Name	Time	Method
Incidence of navigation success;Lesion detection rate;Navigation time;Evaluate the user satisfaction of ENB system and system kit;The adverse events and device defects related to the ENB system and system kit