Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: Navigational Bronchoscopy; Procedure: Standard Bronchoscopy

• Registration Number: NCT01947530
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2019-05-24
• Study Completion: 2019-05-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.

Exclusion Criteria

• Pulmonary nodules less than 1.0 cm
• patients must be able to tolerate general anesthesia
• patients with significant coagulopathy having International Ratio (INR)>2.0 or Prothrombin Time (PTT) >2x normal
• patients unable to tolerate bronchoscopy
• pregnant patients or patients who believe they are pregnant
• patients with implantable devices susceptible to Radio Frequency (RF) fields
• severely obese patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigational Bronch/Standard Bronch	Standard Bronchoscopy	Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
Navigational Bronch/Standard Bronch	Navigational Bronchoscopy	Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
Standard Bronch/Navigational Bronch	Standard Bronchoscopy	Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.
Standard Bronch/Navigational Bronch	Navigational Bronchoscopy	Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.

Primary Outcome Measures

Name	Time	Method
Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy	up to 1 year	This information will be gathered from the pathology report. This report will be completed as soon as possible after the procedure.

Secondary Outcome Measures

Name	Time	Method
Total virtual bronchoscopy time	Day 1	Information will be gathered at time of procedure
Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules	up to 1 year
Total procedure time	Day 1	This information will be gathered at the time of procedure

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada