Olympus - 19-gauge Needle

NCT ID: NCT03270670

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-21

Study Completion Date

2019-01-30

Brief Summary

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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

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Momen Wahidi, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Duke Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00082253

Identifier Type: -

Identifier Source: org_study_id

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