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OpenTrials
Completed

NCT Number: NCT03270670

Olympus - 19-gauge Needle

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University in St. Louis, St Louis, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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).

Treatment and study plan

Primary outcomes

  1. Molecular marker test

    Time frame: Day of Procedure

    Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Pilot Study Evaluating the Performance of 19-gauge Needles in Testing Molecular Markers in Samples Obtained Via Endobronchial Ultrasound Guided Needle Aspiration of Lymph Nodes in Patients With Lung Cancer

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2017
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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