Spots Global Cancer Trial Database for ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
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Trial Identification
Brief Title: 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 ID: NCT04447482
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Affiliated Hospital, Zhejiang University School of Medicine, Hanzhou, Zhejiang, China
Shanghai Changhai Hospital, Shanghai, , China
Shanghai Chest Hospital, Shanghai, , China
Shanghai East Hospital, Shanghai, , China
Contact Details
Name: Cathaly Hong
Affiliation: Shanghai Youhe Medical Technology Co., Ltd.
Role: STUDY_DIRECTOR
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