Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

superDimension Ltd.30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Lung Disease

Interventions

inReach bronchoscopy planning softwareDEVICE

inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.

Standard lung CT viewerDEVICE

CT viewer, used for standard bronchoscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Pulmonology Department, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

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 Outcomes

Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events.

Time frame: At discharge from bronchoscopy unit

Data from ClinicalTrials.gov

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