Olympus - 19-gauge Needle

Completed

• Conditions: Lung Cancer

• Registration Number: NCT03270670
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-21
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular marker test	Day of Procedure	Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing

Trial Locations

Locations (2)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Duke Medical Center; 🇺🇸 Durham, North Carolina, United States