Observational Bronchoscopy Video Data Collection Study With Adult Patients
Collecting Imaging Data From Standard-of-care Bronchoscopies for AI-development: a Prospective, Non-interventional Study (Using CE-marked Bronchoscopes)
1 other identifier
observational
115
1 country
1
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 and using existing bronchoscopy technology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2024
CompletedFirst Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedJune 20, 2024
May 1, 2024
3 months
June 10, 2024
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of bronchial segments accessed during bronchoscopy
Accurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities
1 year
Interventions
No intervention will take place in this study, only image material will be captured from the standard-of-care bronchoscopy
Eligibility Criteria
All adults indicated for a bronchoscopy above 18 year is part of the population.
You may qualify if:
- Patients indicated for bronchoscopy of central airways as per standard of care
- Patients of 18 years or above
You may not qualify if:
- Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
- Patients unable or unwilling to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ambu A/Slead
- Odense University Hospitalcollaborator
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 20, 2024
Study Start
November 8, 2023
Primary Completion
February 9, 2024
Study Completion
February 9, 2024
Last Updated
June 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
The data is collected to develop software, and no intervention will take place. It will therefore not be relevant to share the data with other researchers for further analysis.