Skip to content

Observational Bronchoscopy Video Data Collection Study With Adult Patients

Collecting Imaging Data From Standard-of-care Bronchoscopies for AI-development: a Prospective, Non-interventional Study (Using CE-marked Bronchoscopes)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06465797
Enrollment
115
Registered
2024-06-20
Start date
2023-11-08
Completion date
2024-02-09
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Lung Diseases, Lung Diseases, Obstructive, Lung Neoplasms, Lung Transplantation

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTBronchoscopy

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

Sponsors

Odense University Hospital
CollaboratorOTHER
Ambu A/S
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Number of bronchial segments accessed during bronchoscopy1 yearAccurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026