Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules
Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules
1 other identifier
interventional
11
1 country
1
Brief Summary
The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Sep 2013
Longer than P75 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2019
CompletedMarch 25, 2020
March 1, 2020
5.7 years
September 6, 2013
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules
up to 1 year
Total virtual bronchoscopy time
Day 1
Total procedure time
Day 1
Study Arms (2)
Navigational Bronch/Standard Bronch
ACTIVE COMPARATORPatient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
Standard Bronch/Navigational Bronch
ACTIVE COMPARATORPatient will first have a standard bronchoscopy then a navigational bronchoscopy completed.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 1L7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kazuhiro Yasufuku, MD
UHN
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2013
First Posted
September 20, 2013
Study Start
September 1, 2013
Primary Completion
May 24, 2019
Study Completion
May 24, 2019
Last Updated
March 25, 2020
Record last verified: 2020-03