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OpenTrials
Completed

NCT Number: NCT00817167

Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

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

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Key information

Conditions

Lung Disease Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonology Department, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inReach bronchoscopy planning software

Device

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 viewer

Device

CT viewer, used for standard bronchoscopy

Primary outcomes

  1. 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

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

    Time frame: At discharge from bronchoscopy unit

Sponsors and collaborators

Lead sponsor

superDimension Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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