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Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

This study has been completed.
Information provided by (Responsible Party):
superDimension Ltd. Identifier:
First received: January 1, 2009
Last updated: November 17, 2014
Last verified: November 2014
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: 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


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

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
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Please refer to this study by its identifier: NCT00817167

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

Additional Information:
Responsible Party: superDimension Ltd. Identifier: NCT00817167     History of Changes
Other Study ID Numbers: DPR0006
Study First Received: January 1, 2009
Last Updated: November 17, 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 processed this record on May 24, 2017