UnknownNot applicableNCT05358041
Official study title

Cone Beam CT Guided Robotic Navigational Bronchoscopy

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedRobotic Bronchoscopy

The study team can explain what participation involves.

Who it may be forLung Nodule · Lung Mass

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 3, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Columbus Regional Health

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Columbus Regional Health
Interventions being studied
Device: Robotic Bronchoscopy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Patients with lung nodule
  • Patients with lung mass
  • Patients undergoing navigation bronchoscopy for biopsy of peripheral/central lung lesions.
Reasons someone may not be able to joinExclusion criteria
  • Patients less than 18 years of age
  • Patients unable to complete the navigational bronchoscopy procedure.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Columbus Regional HealthColumbus, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 3, 2022. Always confirm current availability with the study team.

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