Observational Bronchoscopy Video Data Collection Study With Adult Patients

Ambu A/S115 enrolled

Overview

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.

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

115

Conditions

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

Interventions

BronchoscopyDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Number of bronchial segments accessed during bronchoscopy

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

Time frame: 1 year

Data from ClinicalTrials.gov

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