Lung DiseasesNCT06465797
Observational Bronchoscopy Video Data Collection Study With Adult Patients
An observational study of Lung Diseases and Lung Neoplasms, run by Ambu A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Lung Neoplasms, Lung Cancer
- What is being tested?
- Bronchoscopy
- How many people
- 115 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2023to 9 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults indicated for a bronchoscopy above 18 year is part of the population.
Who may be able to join
- Patients indicated for bronchoscopy of central airways as per standard of care
- Patients of 18 years or above
Who cannot join
- Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
- Patients unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collecting Imaging Data From Standard-of-care Bronchoscopies for AI-development: a Prospective, Non-interventional Study (Using CE-marked Bronchoscopes)
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.
Read the detailed description
A data collection of bronchoscopy videos from 100-150 patients are enrolled for getting image material of different lung anatomies, captured with CE-marked and FDA-approved Ambu bronchoscopes (Ambu® aScope™ 5 Broncho HD). No intervention will take place, only standard of care. All types of indications are enrolled. All patients were given oral and written information prior to participating, and signed consent was provided. No patient identifiable information is stored.
- Conditions
- Lung Diseases, Lung Neoplasms, Lung Cancer, Lung Transplantation, Lung Diseases, Obstructive
- Being tested
- Bronchoscopy
- Medical subject headings
- Lung Diseases, Lung Neoplasms, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyDiagnostic test
No intervention will take place in this study, only image material will be captured from the standard-of-care bronchoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bronchial segments accessed during bronchoscopy
Accurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start8 Nov 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambu A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465797
- Sponsor's protocol ID
- Ambu A/S
- Status last verified
- May 2024
- First submitted
- 10 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Imaging Data From Standard-of-care Bronchoscopies for AI-development: a Prospective, Non-interventional Study (Using CE-marked Bronchoscopes)
- ClinicalTrials.gov ID
- NCT06465797
- Acronym / sponsor ID
- Ambu A/S
- Conditions
- Lung Diseases, Lung Neoplasms, Lung Cancer, Lung Transplantation, Lung Diseases, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Ambu A/SIndustry (pharma, biotech, devices)
- Collaborators
- Odense University Hospital
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A data collection of bronchoscopy videos from 100-150 patients are enrolled for getting image material of different lung anatomies, captured with CE-marked and FDA-approved Ambu bronchoscopes (Ambu® aScope™ 5 Broncho HD). No intervention will take place, only standard of care. All types of indications are enrolled. All patients were given oral and written information prior to participating, and signed consent was provided. No patient identifiable information is stored.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults indicated for a bronchoscopy above 18 year is part of the population.
Key inclusion criteria (2 listed)
- Patients indicated for bronchoscopy of central airways as per standard of care
- Patients of 18 years or above
Key exclusion criteria (2 listed)
- Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
- Patients unable or unwilling to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyNo intervention will take place in this study, only image material will be captured from the standard-of-care bronchoscopy | Diagnostic test | – |
Primary outcome
Number of bronchial segments accessed during bronchoscopy
Time frame: 1 year
Accurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Lung Neoplasms, run by Ambu A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bronchial segments accessed during bronchoscopy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.