Lung Cancer
Conditions
Brief summary
The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.
Interventions
PROCEDURENavigational Bronchoscopy
PROCEDUREStandard Bronchoscopy
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Information will be gathered at time of procedure |
| Total procedure time | Day 1 | This information will be gathered at the time of procedure |
Countries
Canada
Outcome results
None listed