Clinical trial NCT04447482: ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Pulmonary Neoplasm
Keywords: Peripheral Pulmonary Lesion
Lung Biopsy
Electromagnetic Navigation Bronchoscopy
Bronchoscopy
Fluoroscopy
Lead sponsor: Shanghai Youhe Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
timeFrame: 6 months.
Secondary outcomes:
measure: Sampling success rate of the treatment group and the control group.
timeFrame: 2 weeks.
measure: Navigation time (time to find the lesions) of the treatment group and the control group.
timeFrame: Duration of procedure, or up to 120 minutes.
measure: Total operation time of the treatment group and the control group.
timeFrame: Duration of procedure, or up to 120 minutes.
measure: Navigation success rate of 4D-ENB and biopsy accessories.
timeFrame: Duration of procedure, or up to 120 minutes.
measure: Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.
timeFrame: Duration of procedure, or up to 120 minutes.
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
Study officials:
affiliation: Shanghai Youhe Medical Technology Co., Ltd.
name: Cathaly Hong
role: STUDY_DIRECTOR
References:
citation: Raval AA, Amir L. Community hospital experience using electromagnetic navigation bronchoscopy system integrating tidal volume computed tomography mapping. Lung Cancer Manag. 2016 Apr;5(1):9-19. doi: 10.2217/lmt-2015-0007. Epub 2016 Apr 8.
citation: Flenaugh, E.L., & Mohammed, K.H.. Initial Experience Using 4D Electromagnetic Navigation Bronchoscopy System With Tip Tracked Instruments For Localization of Peripheral Lung Nodules. The Internet Journal of Pulmonary Medicine 18(1): 1-7, 2016.