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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01947530
Recruitment Status : Active, not recruiting
First Posted : September 20, 2013
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Navigational Bronchoscopy Procedure: Standard Bronchoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules
Study Start Date : September 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Standard Bronchoscope




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947530


Locations
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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 1L7
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Kazuhiro Yasufuku, MD UHN

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01947530     History of Changes
Other Study ID Numbers: 12-5056-B
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019