Cone Beam CT Guided Robotic Navigational Bronchoscopy

Status unconfirmed

Conditions studied: Lung Nodule, Lung Mass, Lung Cancer

In brief

Navigational bronchoscopy (NB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Currently there are multiple platforms available to provide guidance to reach the peripheral and central lesions in the lung which are inaccessible via traditional video bronchoscopy. Traditionally NB is done under fluoroscopic guidance using C-arm but with development of Cone Beam CT and 3D reconstruction technology, fluoroscopy can be enhanced to much higher resolution and can also provide real time 3D augmentation of the lesion. It also enables the user to obtain a CT of the Chest to confirm the real time location of the lesion and the bronchoscopic biopsy catheter and instruments. This has proven to improve the yield and sensitivity of Navigational bronchoscopic guided Biopsy of the lung nodules and masses. Out of the various navigational platforms we have, most of them are based on Electromagnetic guidance and some on Shape sensing technology. Some of the platforms have fixed angle catheter while the newer robotic platforms have articulating catheters with much more range of motion. So far we do not have any data directly comparing the diagnostic yield of Electromagnetic navigational bronchoscopy with Robotic shape sensing guided bronchoscopy while using Cone Beam CT and Augmented fluoroscopy with both the platforms. With my study, I want to examine the change in diagnostic yield and sensitivity of fixed angle ENB guided bronchoscopy and articulating robotic shape sensing bronchoscopy both using Cone Beam CT with 3D reconstruction.

Key facts

Study ID

NCT05358041

Run by

Columbus Regional Health

People needed

200

Starts

2021-11-03

Expected to finish

2022-11-03

Last updated by the study team

2022-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with lung nodule
• Patients with lung mass
• Patients undergoing navigation bronchoscopy for biopsy of peripheral/central lung lesions.

You may not qualify if…

• Patients less than 18 years of age
• Patients unable to complete the navigational bronchoscopy procedure.

Where it is running

• Columbus Regional Health — Columbus, Indiana, United States

Full record on ClinicalTrials.gov

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