Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules

NCT ID: NCT01947530

Last Updated: 2020-03-25

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

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-05-24

Brief Summary

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The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Navigational Bronch/Standard Bronch

Patient will have first the Navigational Bronchoscopy then the standard bronchoscopy completed.

Group Type ACTIVE_COMPARATOR

Navigational Bronchoscopy

Intervention Type PROCEDURE

Standard Bronchoscopy

Intervention Type PROCEDURE

Standard Bronch/Navigational Bronch

Patient will first have a standard bronchoscopy then a navigational bronchoscopy completed.

Group Type ACTIVE_COMPARATOR

Navigational Bronchoscopy

Intervention Type PROCEDURE

Standard Bronchoscopy

Intervention Type PROCEDURE

Interventions

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Navigational Bronchoscopy

Intervention Type PROCEDURE

Standard Bronchoscopy

Intervention Type PROCEDURE

Other Intervention Names

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4-D EM Tip-tracked Devices Veran Navigational System Standard Bronchoscope

Eligibility Criteria

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Inclusion Criteria

* Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.

Exclusion Criteria

* Pulmonary nodules less than 1.0 cm
* patients must be able to tolerate general anesthesia
* patients with significant coagulopathy having International Ratio (INR)\>2.0 or Prothrombin Time (PTT) \>2x normal
* patients unable to tolerate bronchoscopy
* pregnant patients or patients who believe they are pregnant
* patients with implantable devices susceptible to Radio Frequency (RF) fields
* severely obese patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kazuhiro Yasufuku, MD

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12-5056-B

Identifier Type: -

Identifier Source: org_study_id

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