Observational Bronchoscopy Video Data Collection Study With Adult Patients

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.

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Key information

Conditions

Lung Diseases Lung Cancer Lung Diseases, Obstructive Lung Neoplasms Lung Transplantation Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Diagnostic Test

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

Primary outcomes

Number of bronchial segments accessed during bronchoscopy

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Ambu A/S

Industry

Collaborators

Odense University Hospital

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 20, 2024
Registry last updated: Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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