Pilot Study Using Combined Virtual 4-D EM Tip-Tracked Devices and Endobronchial Ultrasound (EBUS)in the Diagnosis of Peripheral Pulmonary Nodules
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Observe yield of EM Tip-tracked Devices compared to standard bronchoscopy
Study Overview
Brief Summary
The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Navigational Bronch/Standard Bronch
Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
Intervention: Navigational Bronchoscopy (Procedure)
Navigational Bronch/Standard Bronch
Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.
Intervention: Standard Bronchoscopy (Procedure)
Standard Bronch/Navigational Bronch
Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.
Intervention: Navigational Bronchoscopy (Procedure)
Standard Bronch/Navigational Bronch
Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.
Intervention: Standard Bronchoscopy (Procedure)
Outcomes
Primary Outcomes
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
- Observe safety of EM Tip-tracked devices in the collection of samples for diagnosis of peripheral nodules(up to 1 year)
- Total procedure time(Day 1)
- Total virtual bronchoscopy time(Day 1)