Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE)
Stopped early · Not applicable
Conditions studied: ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy
In brief
The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.
Key facts
- Study ID
- NCT02028052
- Run by
- Duke University
- People needed
- 37
- Starts
- 2012-04-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2017-02-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject provides informed consent
- Subject is >18 years of age
- Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care
- A negative pregnancy test in women of child-bearing potential
- Subject is mentally capable of following study directions
You may not qualify if…
- Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
- Concurrent participation in another study involving investigational drugs or investigational medical devices
- Inability to read and understand the necessary study documents
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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