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Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00817167
Enrollment
30
Registered
2009-01-06
Start date
2009-01-31
Completion date
2009-12-31
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Disease

Keywords

Known or suspected lung disease, Candidates for non-emergency bronchoscopy

Brief summary

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

Interventions

DEVICEinReach 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.

DEVICEStandard lung CT viewer

CT viewer, used for standard bronchoscopy

Sponsors

superDimension Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026