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CompletedNCT06465797Updated Jun 20, 2024

Observational Bronchoscopy Video Data Collection Study With Adult Patients

An observational study in Lung Diseases, Lung Neoplasms and Lung Cancer, sponsored by Ambu A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by Ambu A/S · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
115
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Lung Diseases
  • Lung Neoplasms
  • Lung Cancer
  • Lung Transplantation
  • Lung Diseases, Obstructive
03

In context

Lung Diseases

3,319 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 115 is below the median of 160 across 939 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Ambu A/S is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adults indicated for a bronchoscopy above 18 year is part of the population.

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.

Inclusion criteria

  • Patients indicated for bronchoscopy of central airways as per standard of care
  • Patients of 18 years or above

Exclusion criteria

Exclusion Criteria:

  • Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
  • Patients unable or unwilling to give informed consent
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testBronchoscopy

    No intervention will take place in this study, only image material will be captured from the standard-of-care bronchoscopy

06

What researchers measure

Primary outcomes

  1. Number of bronchial segments accessed during bronchoscopy

    Accurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities

    Time frame: 1 year

07

Study locations

1 site
  • Odense University Hospital
    Odense, 5000, Denmark
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Feb 2024, 3 months.

Of 52 industry-sponsored observational studies under Lung Diseases, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 34. This study's 3 months is below that.

Counting every sponsor, half of 353 studies reached it within 34 months; a quarter within 17 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2024
First posted
Jun 20, 2024
StartActual
Nov 8, 2023
Primary completionActual
Feb 9, 2024
CompletionActual
Feb 9, 2024
Last update
Jun 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06465797
Lead sponsor
Ambu A/S
Responsible party
Sponsor
First posted
Jun 20, 2024
Start date
Nov 8, 2023
Primary completion
Feb 9, 2024
Completion
Feb 9, 2024
Last update
Jun 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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