Olympus - 19-gauge Needle
Completed
- Conditions
- Lung Cancer
- Registration Number
- NCT03270670
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node >0.5 cm in short axis on EBUS or any lymph node with uptake on FDG-PET scan that is higher than background PET activity.
- Participants must lack bleeding disorders
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Exclusion Criteria
- Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
- Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
- Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Molecular marker test Day of Procedure Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Duke Medical Center
🇺🇸Durham, North Carolina, United States