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Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00817167
First Posted: January 6, 2009
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
superDimension Ltd.
  Purpose
The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.

Condition Intervention
Lung Disease Device: inReach bronchoscopy planning software Device: Standard lung CT viewer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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.

Resource links provided by NLM:


Further study details as provided by superDimension Ltd.:

Primary Outcome Measures:
  • Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures. [ Time Frame: Until the definitive diagnosis is obtained ]

Secondary Outcome Measures:
  • Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events. [ Time Frame: At discharge from bronchoscopy unit ]

Enrollment: 30
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inReach (A)
Bronchoscopy procedure is planned using inReach planning software
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.
Active Comparator: Control (B)
Bronchoscopy procedure is planned using standard CT viewer software
Device: Standard lung CT viewer
CT viewer, used for standard bronchoscopy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817167


Locations
Israel
Pulmonology Department, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
superDimension Ltd.
Investigators
Principal Investigator: Avi Mann, MD Pulmonology Department, Tel Aviv Sourasky Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: superDimension Ltd.
ClinicalTrials.gov Identifier: NCT00817167     History of Changes
Other Study ID Numbers: DPR0006
First Submitted: January 1, 2009
First Posted: January 6, 2009
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by superDimension Ltd.:
Known or suspected lung disease
Candidates for non-emergency bronchoscopy

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases