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

Lung Cancer Clinical Trial

Official title:

Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947530
• Other study ID #: 12-5056-B
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: May 24, 2019

Study information

• Verified date: March 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Navigational Bronchoscopy

• Standard Bronchoscopy

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy	This information will be gathered from the pathology report. This report will be completed as soon as possible after the procedure.	up to 1 year
Secondary	Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules		up to 1 year
Secondary	Total virtual bronchoscopy time	Information will be gathered at time of procedure	Day 1
Secondary	Total procedure time	This information will be gathered at the time of procedure	Day 1