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

Primary Purpose

Bronchial Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
navigated bronchoscopy
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchial Neoplasms focused on measuring Bronchoscopy, Bronchoscopes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy

Sites / Locations

  • Department of Thoracic Medicine, St Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

navigated bronchoscopy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

duration of procedure
time from first entry of endoscope through vocal cords to final withdrawal of endoscope
patient reported satisfaction
enquiry on patients´own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
adverse events
procedure related adverse events or unexpected incidents registrated

Full Information

First Posted
July 1, 2015
Last Updated
March 29, 2016
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, SINTEF Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT02493023
Brief Title
Automatic CT-to-patient Registration During Navigated Bronchoscopy and EBUS
Official Title
Assessment of a Novel, Fast and Automatic CT-to-patient Registration Method During Navigated Bronchoscopy and Endobronchial Ultrasound Bronchoscopy (EBUS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, SINTEF Health Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Neoplasms
Keywords
Bronchoscopy, Bronchoscopes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
navigated bronchoscopy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
navigated bronchoscopy
Other Intervention Name(s)
position tracked bronchoscope, navigated endobronchial ultrasound (EBUS)
Primary Outcome Measure Information:
Title
endoscope position (measured in millimetres from origo in the x, y and z-plane) in 3 dimensional maps from preoperative CT images
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
duration of procedure
Description
time from first entry of endoscope through vocal cords to final withdrawal of endoscope
Time Frame
48 hours
Title
patient reported satisfaction
Description
enquiry on patients´own experience 2 hours after end of navigated bronchoscopy/EBUS procedure
Time Frame
48 hours
Title
adverse events
Description
procedure related adverse events or unexpected incidents registrated
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: referred to thoracic department St Olavs Hospital due to suspicion of lung cancer informed consent Exclusion Criteria: pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toril A Nagelhus Hernes, prof
Organizational Affiliation
Department of Circulation and Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Department of Thoracic Medicine, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26615428
Citation
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.
Results Reference
result

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

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