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NCT06465797 Clinical Trial

Observational Bronchoscopy Video Data Collection Study With Adult Patients

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06465797
Other study ID # Ambu A/S
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2023
Est. completion date February 9, 2024

Study information
Verified date May 2024
Source Ambu A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date February 9, 2024
Est. primary completion date February 9, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Odense University Hospital Odense

Sponsors (2)
Lead Sponsor Collaborator
Ambu A/S Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of bronchial segments accessed during bronchoscopy Accurate procedure recordings by the bronchoscope of all 18 anatomical segments +/- abnormalities 1 year
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