An observational study in Tumor, Hemoptysis and Pulmonary Disease, sponsored by Qmed Consulting A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Qmed Consulting A/S · Observational
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.
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:
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 833 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Qmed Consulting A/S as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The bronchoscope is used to confirm or exclude a diagnosis in adult patients with airway complaints to identify a potential disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Any subject who is scheduled to undergo bronchoscopy as per routine clinical practice
Diagnostic Test: Bronchoscopy
All subjects who are scheduled for a bronchoscopy may be eligible.
Number of anatomical segments accessed during bronchoscopy
accurate photo documentation of all 18 anatomical segments +/- abnormalities
Time frame: 1 day
Number of anatomical segments identified
Identified anatomical segments by the core lab/ Identified anatomical segments by the Machine Learning (after training, using the test videos).
Time frame: 1 day
Rate of total number of lesions detected
total lesions detected by the core lab/ total lesions detected by Machine Learning (after training, using the test videos).
Time frame: 1 day
Number of sections and lesions detected by core lab and machine learning
Anatomical sections + lesions detected by core lab versus anatomical sections + lesions detected by machine learning
Time frame: 1 day
Plan to share: Yes — Provide data to Ambu A/S that can not be identified without the identification log.
Supporting information: Study protocol, Clinical study report
Time frame: 2 years after study end
Access criteria: restricted access with user accounts to electronic data capture system
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Dec 2021, 12 months.
Of 148 industry-sponsored observational studies under Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 102. This study's 12 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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