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Mobile Cone-Beam CT in Combination With Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules
This study aims to evaluate the clinical value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mCBCT in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mCBCT adjustments.
This study is a prospective, single-arm, single-center observational clinical trial to evaluate the diagnostic value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules. The investigators will adjust the position of electromagnetic navigation bronchoscopy base on the intraoperative 3D imaging findings of mCBCT. The value of mCBCT in improving diagnostic yield is explored by comparing the diagnostic yield Post-mCBCT with that of Pre-mCBCT. The Pre-mCBCT diagnostic yield is the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and with no need for adjustment after mCBCT spin confirmed "tool-in-lesion" during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield is the proportion of diagnosed patients with and without adjustment after mCBCT spin during the procedure in all enrolled subjects.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Start Date
September 26, 2022
Primary Completion Date
December 31, 2023
Completion Date
June 30, 2024
Last Updated
September 13, 2023
109
ESTIMATED participants
Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)
DEVICE
Lead Sponsor
Shanghai Chest Hospital
NCT06498635
NCT07336732
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06066138