NCT04758403

CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.

Detailed description

This clinical trial examines the effectiveness of a treatment comparing it to another known treatment. The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease. The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease. This research study involves a screening period, a procedure and follow up visits. The names of the study interventions involved in this study are: * Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB) * Navigation bronchoscopy alone Participants will receive the study procedure and will be followed for up to 6 months. It is expected that about 136 people will take part in this research study.

Conditions

• Peripheral Pulmonary Nodules
• Lung; Node
• Cone Beam Computed Tomography
• Guided Navigation Bronchoscopy

Interventions

Type	Name	Description
RADIATION	Navigation Bronchoscopy	Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
RADIATION	Cone beam computed tomography (CBCT)	Per Protocol

Timeline

• Start date: 2021-03-05
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2021-02-17
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study