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NCT00817167 Clinical Trial

Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

Lung Disease Clinical Trial

Official title:
Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00817167
Other study ID # DPR0006
Secondary ID
Status Completed
Phase N/A
First received January 1, 2009
Last updated November 17, 2014
Start date January 2009
Est. completion date December 2009

Study information
Verified date November 2014
Source superDimension Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• 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.
• Standard lung CT viewer
CT viewer, used for standard bronchoscopy

Locations
Country Name City State
Israel Pulmonology Department, Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
superDimension Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. Epub 2007 Mar 30. — View Citation

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. Epub 2006 Jul 27. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures. Until the definitive diagnosis is obtained No
Secondary Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events. At discharge from bronchoscopy unit Yes
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