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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT. |
|
| Control Group | Active Comparator | Bronchoscopic lung biopsy taken while using X-ray fluoroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENB with image-guided lung biopsy | Device | Electromagnetic navigational bronchoscopy system with tip tracked instruments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate 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. | 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks. |
| Navigation time (time to find the lesions) of the treatment group and the control group. |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be selected:
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathaly Hong | Contact | 8613524168379 | cathaly_hong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Cathaly Hong | Shanghai Youhe Medical Technology Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hanzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30643545 | Background | 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. | |
| Background | 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. |
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| Conventional Bronchoscopy guided by Fluoroscopy | Procedure | Bronchoscopic lung biopsy with fluoroscopy. |
|
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. |
| 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. | 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. | 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. | Duration of procedure, or up to 120 minutes. |
| Shanghai Changhai Hospital | Recruiting | Shanghai | China |
|
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
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| Shanghai East Hospital | Recruiting | Shanghai | China |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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