Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of … (NCT01947530) | Clinical Trial Compass
CompletedNot Applicable
Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules
Canada11 participantsStarted 2013-09
Plain-language summary
The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy