Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by superDimension Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
superDimension Ltd.
ClinicalTrials.gov Identifier:
NCT00817167
First received: January 1, 2009
Last updated: February 18, 2009
Last verified: February 2009
  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
Endpoint Classification: Safety/Efficacy Study
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.

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817167

Contacts
Contact: Avi Mann, MD + 972 3 6973591 mann@tasmc.health.gov.il
Contact: Yehuda Schwarz, MD + 972 3 6973591 schwarz@tasmc.health.gov.il

Locations
Israel
Pulmonology Department, Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Avi Mann, MD    + 972 3 6973591    mann@tasmc.health.gov.il   
Contact: Yehuda Schwarz, MD    + 972 3 6973591    schwarz@tasmc.health.gov.il   
Principal Investigator: Avi Mann, MD         
Sub-Investigator: Yehuda Schwarz, MD         
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: Noreen Thompson / VP Marketing, superDimension Inc.
ClinicalTrials.gov Identifier: NCT00817167     History of Changes
Other Study ID Numbers: DPR0006
Study First Received: January 1, 2009
Last Updated: February 18, 2009
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014