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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
212
Electromagnetic navigational bronchoscopy system with tip tracked instruments.
Bronchoscopic lung biopsy with fluoroscopy.
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
RECRUITINGShanghai Changhai Hospital
Shanghai, China
RECRUITINGShanghai Chest Hospital
Shanghai, China
RECRUITINGEvaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
Diagnostic rate is defined as the proportion of true positive and true negative.
Time frame: 6 months.
Sampling success rate of the treatment group and the control group.
Sampling success rate means the proportion of lung nodules and abnormal lung tissues in all tissues sampled from bronchoscopic lung biopsy.
Time frame: 2 weeks.
Navigation time (time to find the lesions) of the treatment group and the control group.
For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to the biopsy tool reaching the lesion.
Time frame: Duration of procedure, or up to 120 minutes.
Total operation time of the treatment group and the control group.
For this outcome, duration of procedure is defined as the time from the bronchoscopy accessing the glottis for the first time to bronchoscopy exiting the glottis for the last time.
Time frame: Duration of procedure, or up to 120 minutes.
Navigation success rate of 4D-ENB and biopsy accessories.
Navigation success rate is defined as the proportion of the biopsy tools reaching the lung tissues. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.
Time frame: Duration of procedure, or up to 120 minutes.
Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.
Device performance means the functions, reliability, safety and accessibility of the system. Performance will be evaluated by observing these characteristics during the procedure. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai East Hospital
Shanghai, China
RECRUITINGTime frame: Duration of procedure, or up to 120 minutes.