Skip to main content
OpenTrials
Completed

NCT Number: NCT01947530

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 1L7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigational Bronchoscopy

Procedure

Other names: 4-D EM Tip-tracked Devices, Veran Navigational System

Standard Bronchoscopy

Procedure

Other names: Standard Bronchoscope

Primary outcomes

  1. 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.

Secondary outcomes

  1. Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules

    Time frame: up to 1 year

  2. Total virtual bronchoscopy time

    Time frame: Day 1

    Information will be gathered at time of procedure

  3. Total procedure time

    Time frame: Day 1

    This information will be gathered at the time of procedure

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2013
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.