ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions

A Prospective, Randomized, Multi-center, Superiority Clinical Study to Evaluate the Effectiveness and Safety of Bronchoscopic Lung Biopsy Under the Guide of CT Stereotactic Auxiliary Equipment and Accessories

Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer.

The objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions: either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated. This is a prospective, randomized, multi-center study.

Inclusion Criteria:

• Subjects must meet all of the following criteria to be selected:

  1. Be older than 18 (including 18) and younger than 75 (including 75);
  2. The population with peripheral lung lesions detected in chest CT scanning and who require biopsy;
  3. The subjects are willing to undergo bronchoscopy and meet the requirements for bronchoscopy;
  4. The subjects or their guardians can understand the trial objective, volunteer to participate and sign the informed consent form.

Exclusion Criteria:

• Subjects will be excluded if they meet any of the following criteria:

  1. The patient is participating in another drug or medical device clinical trial (drug clinical trial within 3 months or medical device clinical trial within 1 month);
  2. Women of childbearing age who have positive pregnancy test result and lactating women;
  3. Allergic to anesthetics;
  4. Bronchoscopy contraindications, including: active massive hemoptysis; recent myocardial infarction or unstable angina pectoris; severe heart and lung dysfunction; severe hypertension and arrhythmia; uncorrectable bleeding tendency (such as severe coagulation disorders, uremia and severe pulmonary hypertension); severe superior vena cava obstruction syndrome; suspected aortic aneurysm; multiple pulmonary bullae; systemically extreme exhaustion.
  5. Visible intraluminal lesions found during bronchoscopy;
  6. Patients with severe lung diseases (including: severe bronchodilatation, severe emphysema, etc.) and patients determined to be unsuitable for the examination by the investigators;
  7. Patients with a pacemaker or defibrillator;
  8. Patients who cannot cooperate with the doctor to complete bronchoscopy, such as patients with mental and neurological diseases, mental retardation and mental disorders;
  9. Patients to whom bronchoscopy and bronchoscopic sampling are not applicable to diagnose the lesions, or other patients determined to be unsuitable for this trial by the investigators.