Cone Beam CT Guided Robotic Navigational Bronchoscopy

NCT05358041 | Unknown DMC

• 1 other identifier: 007
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Nodule; Lung Mass; Lung Cancer

Keywords

Lung Nodule; Lung Mass; Lung Lesion; Cone Beam CT CT Augmented Fluoroscopy; Electromagnetic Navigation Bronchoscopy; Robotic Navigation Bronchoscopy; Shape Sensing Navigational Bronchoscopy

Outcome Measures

Primary Outcomes (2)

• Sensitivity for malignancy

  Percentage of malignant lesions accurately diagnosed on biopsy

  1 year

• Diagnostic Yield

  Percentage of correct underlying diagnosis

  1 year

Secondary Outcomes (3)

• Procedural Complications

  1 year

• Intra-Operative time

  1 year

• Radiation Exposure

  1 year

Study Arms (2)

Electromagnetic Navigational Fixed Angle Bronchoscopy with CBCT Guidance

Patient is undergoing electromagnetic navigation bronchoscopy using Medtronic super D version 7 EMN system, peripheral endobronchial ultrasound and Cone Beam CT Guidance using the Philips Azurion 7 C20 FlexMove with Embo Guide and Overlay software to create CT Augmented Fluoroscopy under general anesthesia.

Robotic Shape Sensing Bronchoscopy with CBCT Guidance

Patient is undergoing robotic navigation bronchoscopy using IOn robotic platform, peripheral endobronchial ultrasound and Cone Beam CT Guidance using the Philips Azurion 7 C20 FlexMove with Embo Guide and Overlay software to create CT Augmented Fluoroscopy under general anesthesia.

Device: Robotic Bronchoscopy

Interventions

Robotic Bronchoscopy DEVICE

Replace the Super-D EMN navigational platform with Ion Robotic bronchoscopy platform guided with shape sensing technology

Robotic Shape Sensing Bronchoscopy with CBCT Guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung nodule, mass or lesion undergoing navigation bronchoscopy for biopsy. Majority of the patients are smokers. Some of the patients are found to have the lung nodule, mass or lesion incidentally or on the low-dose CT for lung cancer screening.

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.

Sponsors & Collaborators

• Columbus Regional Health: lead

Study Sites (1)

Columbus Regional Health

Columbus, Indiana, 47201, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Lung Institute and Section Chief, Pulmonary & Critical Care

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 3, 2022
• Study Start: November 3, 2021
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)