Airway ObstructionNCT04846153
Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images
A study testing Human-based Quantification of Airway Stenosis and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images. in people with Airway Obstruction, run by Brigham and Women's Hospital.
Trial summary
This is a pilot study to assess the utility of the automatic stenosis index quantification using 3D Slicer software (Computer-based Quantification). We will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (Human-based Quantification). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Human-based Quantification of Airway Stenosis and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2021to 16 Jul 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians who are trained in bronchoscopy.
- Physicians who are willing and able to understand the scope of the study.
Who cannot join
- Physicians who are not trained in bronchoscopy.
- Physicians who are unwilling and unable to understand the study procedure
- Employees under the direct supervision of the investigators conducting the research
Trial locations and contacts
No sites are listed yet.
Artur Banach, MRes contact
About this study
This is a pilot study to assess the utility of the automatic stenosis index quantification using 3D Slicer software (Computer-based Quantification). We will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (Human-based Quantification). This study relates to the latter data collection.
- Conditions
- Airway Obstruction
- Being tested
- Human-based Quantification of Airway Stenosis, Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
- Keywords
- Airway Stenosis, Stenosis Index Quantification
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human-based Quantification of Airway StenosisOther
Human-based Quantification of Airway Stenosis From Bronchoscopic Images.
Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.Device
Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
| Study group | Role | What they receive |
|---|---|---|
| Human-based Quantification | Other | No intervention. No support tool will be used for quantifying airway stenosis from the bronchoscopic images collected previously. Receives: Other: Human-based Quantification of Airway Stenosis |
| Computer-based Quantifiction | Active comparator | Computer based support tool will quantifying airway stenosis from the bronchoscopic images collected previously. Receives: Device: Computer-based Quantification of Airway Stenosis From Bronchoscopic Images. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stenosis index quantified [0-100%]
The stenosis index quantified subjectively by the physician, defined ration between cross-sectional area of the obstructed airway and that of a normal airway.
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 posted15 Apr 2021
- Study start16 Apr 2021 (estimated)
- Primary completion16 Apr 2021 (estimated)
- Study completion16 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Physicians enrolling the study are exclusively assigned to Human-based Quantification.
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuhiko Hata, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846153
- Sponsor's protocol ID
- AirwayStenosis2021
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images
- ClinicalTrials.gov ID
- NCT04846153
- Acronym / sponsor ID
- AirwayStenosis2021
- Conditions
- Airway Obstruction
- Keywords
- Airway Stenosis, Stenosis Index Quantification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 16 Apr 2021 (estimated)
- Primary completion
- 16 Apr 2021 (estimated)
- Study completion
- 16 Jul 2021 (estimated)
- First posted
- 15 Apr 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.
This is a pilot study to assess the utility of the automatic stenosis index quantification using 3D Slicer software (Computer-based Quantification). We will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (Human-based Quantification). This study relates to the latter data collection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Physicians enrolling the study are exclusively assigned to Human-based Quantification.
| Arm | Type | Receives |
|---|---|---|
| Human-based Quantification | Other | Other: Human-based Quantification of Airway StenosisNo intervention. No support tool will be used for quantifying airway stenosis from the bronchoscopic images collected previously. |
| Computer-based Quantifiction | Active comparator | Device: Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.Computer based support tool will quantifying airway stenosis from the bronchoscopic images collected previously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physicians who are trained in bronchoscopy.
- Physicians who are willing and able to understand the scope of the study.
Key exclusion criteria (3 listed)
- Physicians who are not trained in bronchoscopy.
- Physicians who are unwilling and unable to understand the study procedure
- Employees under the direct supervision of the investigators conducting the research
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 |
|---|---|---|
| Human-based Quantification of Airway StenosisHuman-based Quantification of Airway Stenosis From Bronchoscopic Images. | Other | Human-based Quantification |
| Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.Computer-based Quantification of Airway Stenosis From Bronchoscopic Images. | Device | Computer-based Quantifiction |
Primary outcome
Stenosis index quantified [0-100%]
Time frame: 1 year
The stenosis index quantified subjectively by the physician, defined ration between cross-sectional area of the obstructed airway and that of a normal airway.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: No. Currently, there is no plan to share IPD.
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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.
Artur Banach, MRes contact
Questions about this trial
What is this clinical trial studying?
A study testing Human-based Quantification of Airway Stenosis and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images. in people with Airway Obstruction, run by Brigham and Women's Hospital.
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 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: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nobuhiko Hata, PhD (617-732-5809, hata@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stenosis index quantified [0-100%] (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 15 Apr 2021.