Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

Not Applicable

Completed

• Conditions: Lung Disease

• Registration Number: NCT00817167
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-01
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.	At discharge from bronchoscopy unit

Trial Locations

Locations (1)

Pulmonology Department, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel