Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

NCT ID: NCT00817167

Last Updated: 2014-11-19

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.

Detailed Description

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Conditions

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Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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inReach (A)

Bronchoscopy procedure is planned using inReach planning software

Group Type EXPERIMENTAL

inReach bronchoscopy planning software

Intervention Type DEVICE

inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.

Control (B)

Bronchoscopy procedure is planned using standard CT viewer software

Group Type ACTIVE_COMPARATOR

Standard lung CT viewer

Intervention Type DEVICE

CT viewer, used for standard bronchoscopy

Interventions

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inReach bronchoscopy planning software

inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.

Intervention Type DEVICE

Standard lung CT viewer

CT viewer, used for standard bronchoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Candidates for non-emergency bronchoscopy
* Must provide signed informed consent
* Male or female above 18 years old
* Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope

Exclusion Criteria

* CT done over a month before the bronchoscopy procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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superDimension Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Avi Mann, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonology Department, Tel Aviv Sourasky Medical Center

Locations

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Pulmonology Department, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988.

Reference Type BACKGROUND
PMID: 16608948 (View on PubMed)

Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27.

Reference Type BACKGROUND
PMID: 16873767 (View on PubMed)

Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007 Jun;131(6):1800-5. doi: 10.1378/chest.06-3016. Epub 2007 Mar 30.

Reference Type BACKGROUND
PMID: 17400670 (View on PubMed)

Related Links

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Other Identifiers

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DPR0006

Identifier Type: -

Identifier Source: org_study_id