Danish company started a clinical trial to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy
Photo by Hush Naidoo
The company Qmed Consulting A/S is conducting the clinical trial Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.
The primary aim of this study 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.
It is planned to include 2000 participants.
Actual study start date is December 1, 2020. The researchers expect to complete the study by December 31, 2021.
One primary outcome measure is Number of anatomical segments accessed during bronchoscopy, accurate photo documentation of all 18 anatomical segments +/- abnormalities.
The population that can be enrolled into this study includes the patients indicated for full airway bronchoscopy. The bronchoscope is used to confirm or exclude a diagnosis in adult patients with airway complaints to identify a potential disease.
There are a number of conditions that do not allow participation, such as:
- Participant 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 etc).
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04770675) Copenhagen, Denmark.
