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Completed

NCT Number: NCT02493023

Automatic CT-to-patient Registration During Navigated Bronchoscopy and EBUS

Bronchoscopic diagnosis and staging of lung cancer must be gentle and quick, and requires optimal sampling precision.Electromagnetic navigation systems are promising for intraoperative guiding based on maps made of preoperative CT images. Navigation accuracy depends largely on correct alignment of preoperative images to the patient´s position in space during endoscopy. In this study, the accuracy of a new fast and automatic image-to-patient registration method during the initial phase of bronchoscopy is assessed in patients referred for lung cancer investigation.

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Key information

Conditions

Bronchial Neoplasms Bronchial Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Medicine, St Olavs Hospital

Trondheim, Norway

About this study

This is an accuracy study of a new automatic CT-to-patient registration technique for bronchoscopy and endobronchial ultrasound bronchoscopy (EBUS). An in-house research and development navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its exact position in three-dimensional (3D) maps made from the patients' own preoperative CT images. The navigation system is used for acquiring position data from a bronchoscope or EBUS-scope (same sort of output data acquired from both endoscopes in this study) equipped with a position sensor for electromagnetic tracking. From intraoperative position data, the accuracy of the image-to-patient registration and the navigation system accuracy can be calculated. When targeting a certain lymph node or tumor for sampling, the pulmonologist can use electromagnetic navigation combined with preoperative CT images to navigate directly, precisely and accurately to the area of interest. Functional systems for navigated bronchoscopy and EBUS may therefore lead to considerable improvements in lung cancer diagnosis and mediastinal staging.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
  • informed consent

Exclusion criteria

  • pregnancy

Treatment and study plan

navigated bronchoscopy

Device

Other names: position tracked bronchoscope, navigated endobronchial ultrasound (EBUS)

Primary outcomes

  1. endoscope position (measured in millimetres from origo in the x, y and z-plane) in 3 dimensional maps from preoperative CT images

    Time frame: 48 hours

    intraoperative positional data of bronchoscope or endobronchial ultrasound scope (EBUS) measured and stored in navigation system software, used for registration and navigation system accuracy calculations

Secondary outcomes

  1. duration of procedure

    Time frame: 48 hours

    time from first entry of endoscope through vocal cords to final withdrawal of endoscope

  2. patient reported satisfaction

    Time frame: 48 hours

    enquiry on patients´own experience 2 hours after end of navigated bronchoscopy/EBUS procedure

  3. adverse events

    Time frame: 48 hours

    procedure related adverse events or unexpected incidents registrated

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology
  • SINTEF Health Research

Registry information

Official study title

Assessment of a Novel, Fast and Automatic CT-to-patient Registration Method During Navigated Bronchoscopy and Endobronchial Ultrasound Bronchoscopy (EBUS)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 9, 2015
Registry last updated
Mar 30, 2016

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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