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)

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Lung Neoplasms; Lung Diseases, Obstructive; Lung Cancer; Lung Transplantation
• Intervention / Treatment: Diagnostic test: Bronchoscopy

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.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ambu A/S
• Collaborators: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Lung Diseases, Obstructive; Lung Neoplasms
• Other Study ID Numbers: Ambu A/S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No