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Electromagnetic Navigation for Peripheral Pulmonary Lesions

NCT02582944 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-12-26

No results posted yet for this study

Summary

Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery. The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter. This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.

Conditions

  • Peripheral Lung Lesions

Interventions

DEVICE

Olympus BF-180 bronchoscope (standard adult)

-Standard of care

DEVICE

Veran Spinview Thoracic Navigation System

-Electromagnetic navigation

DEVICE

Olympus UM-S20-17S

-Endobronchial ultrasound mini-probe

PROCEDURE

Biopsy

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Alexander Chen, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2017-05-19
Completion
2017-05-19
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02582944 on ClinicalTrials.gov