NCT00817167

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

January 1, 2009

Last Update Submit

November 17, 2014

Conditions

Lung Disease

Keywords

Known or suspected lung diseaseCandidates for non-emergency bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.

    At discharge from bronchoscopy unit

Study Arms (2)

inReach (A)

EXPERIMENTAL

Bronchoscopy procedure is planned using inReach planning software

Device: inReach bronchoscopy planning software

Control (B)

ACTIVE COMPARATOR

Bronchoscopy procedure is planned using standard CT viewer software

Device: Standard lung CT viewer

Interventions

inReach bronchoscopy planning softwareDEVICE

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

inReach (A)
Standard lung CT viewerDEVICE

CT viewer, used for standard bronchoscopy

Control (B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • CT done over a month before the bronchoscopy procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonology Department, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (3)

  • 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.

    PMID: 16608948BACKGROUND

  • 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.

    PMID: 16873767BACKGROUND

  • 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.

    PMID: 17400670BACKGROUND

Related Links

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Avi Mann, MD

    Pulmonology Department, Tel Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2009

First Posted

January 6, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

IL(1)