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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02493023
Enrollment
26
Registered
2015-07-09
Start date
2011-10-31
Completion date
2015-08-31
Last updated
2016-03-30

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

Conditions

Bronchial Neoplasms

Keywords

Bronchoscopy, Bronchoscopes

Brief summary

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.

Detailed description

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.

Interventions

Sponsors

Norwegian University of Science and Technology
CollaboratorOTHER
SINTEF Health Research
CollaboratorOTHER
St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* pregnancy

Design outcomes

Primary

MeasureTime frameDescription
endoscope position (measured in millimetres from origo in the x, y and z-plane) in 3 dimensional maps from preoperative CT images48 hoursintraoperative 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

MeasureTime frameDescription
duration of procedure48 hourstime from first entry of endoscope through vocal cords to final withdrawal of endoscope
patient reported satisfaction48 hoursenquiry on patients´own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
adverse events48 hoursprocedure related adverse events or unexpected incidents registrated

Countries

Norway

Outcome results

None listed

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