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

March 23, 2020 updated by: University Health Network, Toronto

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1L7
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Navigational Bronch/Standard Bronch
Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
Procedure: Navigational Bronchoscopy
Other Names:
  • 4-D EM Tip-tracked Devices
  • Veran Navigational System
Procedure: Standard Bronchoscopy
Other Names:
  • Standard Bronchoscope
Active Comparator: Standard Bronch/Navigational Bronch
Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.
Procedure: Navigational Bronchoscopy
Other Names:
  • 4-D EM Tip-tracked Devices
  • Veran Navigational System
Procedure: Standard Bronchoscopy
Other Names:
  • Standard Bronchoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy
Time Frame: 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.
up to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 24, 2019

Study Completion (Actual)

May 24, 2019

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 12-5056-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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