TerminatedNot Applicable

Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE)

Stopped: similar study data published

United States37 participantsStarted 2012-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Time lapse

Timeframe: during procedure, approximately 45 minutes

Trial details

NCT IDNCT02028052

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

View on ClinicalTrials.gov More ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION trials