Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy
Not Applicable
Completed
- Conditions
- Lung Disease
- Interventions
- Device: Standard lung CT viewerDevice: inReach bronchoscopy planning software
- 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
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
- Arm && Interventions
Group Intervention Description Control (B) Standard lung CT viewer Bronchoscopy procedure is planned using standard CT viewer software inReach (A) inReach bronchoscopy planning software Bronchoscopy procedure is planned using inReach planning software
- 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