Status:
COMPLETED
Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.
Lead Sponsor:
Qmed Consulting A/S
Collaborating Sponsors:
Ambu A/S
Conditions:
Tumor
Hemoptysis
Eligibility:
All Genders
18+ years
Brief Summary
The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure ...
Detailed Description
2.000 subjects, preferable 150-200 number of patients per site. The 2.000 videos will be divided into an 80%/20% split (training and testing). It is a wish to obtain a spread of videos coming from acr...
Eligibility Criteria
Inclusion
- Oral and written participant information has been given (NA for Denmark)
- The subject has signed informed consent (NA for Denmark)
- Patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments)
- Patients older than 18
Exclusion
- Subject with serious lung disease which investigator considers not appropriate for this examination.
- Lack of patient cooperation for bronchoscopy (patient with mental disorders, dysgnosia, psychological disorder…)
- Subjects unable to give consent (NA for Denmark)
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
833 Patients enrolled
Trial Details
Trial ID
NCT04770675
Start Date
December 1 2020
End Date
December 31 2021
Last Update
May 3 2022
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100