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CompletedNCT03270670Updated Sep 10, 2019

Olympus - 19-gauge Needle

An observational study in Lung Cancer, sponsored by Duke University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by Duke University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects undergoing a standard of care bronchoscopy to determine lung cancer.

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

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).
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Molecular marker test

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

    Time frame: Day of Procedure

06

Study locations

2 sites
  • Washington University in St. Louis
    Saint Louis, Missouri 63130, United States
  • Duke Medical Center
    Durham, North Carolina 27710, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03270670
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Aug 21, 2017
Primary completion
Jan 30, 2019
Completion
Jan 30, 2019
Last update
Sep 10, 2019

Study contacts

Momen Wahidi, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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