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

NCT02028052 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-02-15

No results posted yet for this study

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.

Conditions

  • ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION
  • Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy

Interventions

PROCEDURE

ROSE

The procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE.

DEVICE

22 gauge Vizishot needles

Sponsors & Collaborators

Principal Investigators

  • Momen Wahidi, MD, MBA · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028052 on ClinicalTrials.gov