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)
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMarch 30, 2016
March 1, 2016
3.8 years
July 1, 2015
March 29, 2016
Conditions
Keywords
Outcome Measures
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
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
48 hours
Secondary Outcomes (3)
duration of procedure
48 hours
patient reported satisfaction
48 hours
adverse events
48 hours
Study Arms (1)
navigated bronchoscopy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
- informed consent
You may not qualify if:
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
- SINTEF Health Researchcollaborator
Study Sites (1)
Department of Thoracic Medicine, St Olavs Hospital
Trondheim, Norway
Related Publications (1)
Sorger H, Hofstad EF, Amundsen T, Lango T, Leira HO. A novel platform for electromagnetic navigated ultrasound bronchoscopy (EBUS). Int J Comput Assist Radiol Surg. 2016 Aug;11(8):1431-43. doi: 10.1007/s11548-015-1326-7. Epub 2015 Nov 28.
PMID: 26615428RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toril A Nagelhus Hernes, prof
Department of Circulation and Imaging
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 9, 2015
Study Start
October 1, 2011
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
March 30, 2016
Record last verified: 2016-03