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Electromagnetic Navigation for Peripheral Pulmonary Lesions

NCT ID: NCT02582944

Last Updated: 2017-12-26

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

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-25

Study Completion Date

2017-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Lung Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1: Electromagnetic navigation

* The bronchoscope will be inserted transorally into the tracheobronchial tree and a standard airway inspection will be performed.
* Following airway inspection, the bronchoscope will be removed and the tip tracked steerable catheter with optical system will be advanced transorally through the vocal cords and into the tracheobronchial tree.
* Once the tip tracked catheter has been advanced to the peripheral pulmonary target lesion, the optical SpinView system will be removed from the tip tracked catheter and the 1.4mm radial endobronchial ultrasound mini-probe will be inserted through the tip-tracked catheter into the lung periphery to confirm the presence of a peripheral pulmonary lesion and accurate navigation.
* Once target confirmation has been performed using radial probe endobronchial ultrasound, biopsy of the peripheral lesion will be performed using biopsy forceps, brushes and aspiration needles.

Group Type EXPERIMENTAL

Olympus BF-180 bronchoscope (standard adult)

Intervention Type DEVICE

-Standard of care

Veran Spinview Thoracic Navigation System

Intervention Type DEVICE

-Electromagnetic navigation

Olympus UM-S20-17S

Intervention Type DEVICE

-Endobronchial ultrasound mini-probe

Biopsy

Intervention Type PROCEDURE

Interventions

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Olympus BF-180 bronchoscope (standard adult)

-Standard of care

Intervention Type DEVICE

Veran Spinview Thoracic Navigation System

-Electromagnetic navigation

Intervention Type DEVICE

Olympus UM-S20-17S

-Endobronchial ultrasound mini-probe

Intervention Type DEVICE

Biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with peripheral lung lesions 1-7cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
* Are at least 18 years old
* Are able to provide informed consent

Exclusion Criteria

* Patients who refuse to participate
* Are less than 18 years of age
* Are pregnant
* Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
* Are unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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201502080

Identifier Type: -

Identifier Source: org_study_id