Olympus - 19-gauge Needle

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03270670

Enrollment

Registered

2017-09-01

Start date

2017-08-21

Completion date

2019-01-30

Last updated

2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results