Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT04770675
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 and using existing bronchoscopy technology.
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Notify Me18 year and older
All sexes
Observational
Copenhagen, 2100, Denmark
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 across Europe, preferable from Germany, France and Denmark, with up to 800 videos coming from Denmark
The patient population indicated are patients indicated for full airway bronchoscopy. Of this group it is the aim to enrol the following:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All subjects who are scheduled for a bronchoscopy may be eligible.
Time frame: 1 day
accurate photo documentation of all 18 anatomical segments +/- abnormalities
Time frame: 1 day
Identified anatomical segments by the core lab/ Identified anatomical segments by the Machine Learning (after training, using the test videos).
Time frame: 1 day
total lesions detected by the core lab/ total lesions detected by Machine Learning (after training, using the test videos).
Time frame: 1 day
Anatomical sections + lesions detected by core lab versus anatomical sections + lesions detected by machine learning
Qmed Consulting A/S
Industry
A Prospective, Multicenter, Post Market Study to Collect Data for Software Recognizing the Anatomical Structures as Well as Abnormalities in the Lung During a Bronchoscopy.
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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