TumorNCT04770675
Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.
An observational study of Tumor and Hemoptysis, run by Qmed Consulting 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
- Tumor, Hemoptysis, Pulmonary Disease
- What is being tested?
- Bronchoscopy
- How many people
- 833 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2020to 31 Dec 2021
- 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: The bronchoscope is used to confirm or exclude a diagnosis in adult patients with airway complaints to identify a potential disease.
Who may be able to join
- Oral and written participant information has been given (NA for Denmark)
- The subject has signed informed consent (NA for Denmark)
- Patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments)
- Patients older than 18
Who cannot join
- Subject 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…)
- Subjects unable to give consent (NA for Denmark)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
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:
- Patients with obstructing tumors (when tumor blocks the view of the camera) - no more than 5% (120 patients) of studies
- Bronchoscopies on indication of haemoptysis (active bleeding) - no more than 5% (120 patients) of studies
- Patients with stents or valves - no more than 5% (120 patients) of studies bronchoscopies.
- Patients with former lung operations, partial or full resections - no more than 2% (48 patients).
- Conditions
- Tumor, Hemoptysis, Pulmonary Disease
- Being tested
- Bronchoscopy
- Keywords
- bronchoscope
- Medical subject headings
- Neoplasms, Hemoptysis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyDiagnostic test
All subjects who are scheduled for a bronchoscopy may be eligible.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Any subject who is scheduled to undergo bronchoscopy as per routine clinical practice Receives: Diagnostic Test: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anatomical segments accessed during bronchoscopy
accurate photo documentation of all 18 anatomical segments +/- abnormalities
Measured: 1 day
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qmed Consulting A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ambu A/S
- Responsible party
- Sponsor
- Investigators
- Michael Perch, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770675
- Sponsor's protocol ID
- CIS-20
- Status last verified
- May 2022
- First submitted
- 12 Feb 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Provide data to Ambu A/S that can not be identified without the identification log.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04770675
- Acronym / sponsor ID
- CIS-20
- Conditions
- Tumor, Hemoptysis, Pulmonary Disease
- Keywords
- bronchoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- Qmed Consulting A/SIndustry (pharma, biotech, devices)
- Collaborators
- Ambu A/S
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Feb 2021 (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
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:
- Patients with obstructing tumors (when tumor blocks the view of the camera) - no more than 5% (120 patients) of studies
- Bronchoscopies on indication of haemoptysis (active bleeding) - no more than 5% (120 patients) of studies
- Patients with stents or valves - no more than 5% (120 patients) of studies bronchoscopies.
- Patients with former lung operations, partial or full resections - no more than 2% (48 patients).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Diagnostic Test: BronchoscopyAny subject who is scheduled to undergo bronchoscopy as per routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The bronchoscope is used to confirm or exclude a diagnosis in adult patients with airway complaints to identify a potential disease.
Key inclusion criteria (4 listed)
- Oral and written participant information has been given (NA for Denmark)
- The subject has signed informed consent (NA for Denmark)
- Patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments)
- Patients older than 18
Key exclusion criteria (3 listed)
- Subject 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…)
- Subjects unable to give consent (NA for Denmark)
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 |
|---|---|---|
| BronchoscopyAll subjects who are scheduled for a bronchoscopy may be eligible. | Diagnostic test | Treatment group |
Primary outcome
Number of anatomical segments accessed during bronchoscopy
Time frame: 1 day
accurate photo documentation of all 18 anatomical segments +/- abnormalities
3 secondary outcomes
Number of anatomical segments identified
Time frame: 1 day
Rate of total number of lesions detected
Time frame: 1 day
Number of sections and lesions detected by core lab and machine learning
Time frame: 1 day
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 3 May 2022.
- Individual participant dataSharing planned: Yes. Provide data to Ambu A/S that can not be identified without the identification log.
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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.
Michael Perch, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Tumor and Hemoptysis, run by Qmed Consulting 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 4 inclusion and 3 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 3 May 2022. 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 anatomical segments accessed during bronchoscopy (time frame: 1 day). 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 3 May 2022.