Status:
COMPLETED
Olympus - 19-gauge Needle
Lead Sponsor:
Duke University
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
August 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03270670
Start Date
August 21 2017
End Date
January 30 2019
Last Update
September 10 2019
Active Locations (2)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63130
2
Duke Medical Center
Durham, North Carolina, United States, 27710