Clinical trial · Interventional
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
NCT04447482CI-TRIAL-00050751unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pulmonary Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Bronchoscopy guided by Fluoroscopy | Procedure | — | UNRESOLVED |
| ENB with image-guided lung biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- 4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.
- interventionNames
- Device: ENB with image-guided lung biopsy
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.
- interventionNames
- Procedure: Conventional Bronchoscopy guided by Fluoroscopy
Primary outcomes (1)
- measure
- Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDRaval 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. PMID 30643545
- BACKGROUNDFlenaugh, 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.