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

Shanghai Youhe Medical Technology

Status: Unknown

Conditions: Lung Neoplasms; Pulmonary Neoplasm

Treatments: Device: ENB with image-guided lung biopsy; Procedure: Conventional Bronchoscopy guided by Fluoroscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447482

202001131102-CT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Treatment Group

Experimental group

Description:

4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.

Treatment:

Device: ENB with image-guided lung biopsy

Control Group

Active Comparator group

Description:

Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.

Treatment:

Procedure: Conventional Bronchoscopy guided by Fluoroscopy