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Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

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ClinicalTrials.gov Identifier: NCT00817167
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
superDimension Ltd.

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

Condition or disease Intervention/treatment Phase
Lung Disease Device: inReach bronchoscopy planning software Device: Standard lung CT viewer Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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.
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events. [ Time Frame: At discharge from bronchoscopy unit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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