Olympus - 19-gauge Needle

Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270670
• Other study ID #: Pro00082253
• Status: Completed
• Start date: August 21, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: September 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United States	Duke Medical Center	Durham	North Carolina
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular marker test	Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing	Day of Procedure