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Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )

NCT02146131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2018-09-25

Study results available
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Summary

The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs.

This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.

Conditions

  • Pulmonary Lesions
  • Pulmonary Nodules
  • Pulmonary Mass

Interventions

DEVICE

Standard FB with fluoroscopy

Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions

DEVICE

R-EBUS with ultrathin bronchoscope

Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions

Sponsors & Collaborators

  • Olympus

    collaborator INDUSTRY

  • Johns Hopkins University

    collaborator OTHER

  • Medstar Health Research Institute

    collaborator OTHER

  • Mayo Clinic

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Nichole T Tanner, MD, M.S.C.R · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-07-14
Completion
2017-07-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02146131 on ClinicalTrials.gov