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| Name | Class |
|---|---|
| Ambu A/S | INDUSTRY |
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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.
2.000 subjects, preferable 150-200 number of patients per site. The 2.000 videos will be divided into an 80%/20% split (training and testing). It is a wish to obtain a spread of videos coming from across Europe, preferable from Germany, France and Denmark, with up to 800 videos coming from Denmark
The patient population indicated are patients indicated for full airway bronchoscopy. Of this group it is the aim to enrol the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Any subject who is scheduled to undergo bronchoscopy as per routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopy | Diagnostic Test | All subjects who are scheduled for a bronchoscopy may be eligible. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of anatomical segments accessed during bronchoscopy | accurate photo documentation of all 18 anatomical segments +/- abnormalities | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of anatomical segments identified | Identified anatomical segments by the core lab/ Identified anatomical segments by the Machine Learning (after training, using the test videos). | 1 day |
| Rate of total number of lesions detected |
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Inclusion Criteria:
Exclusion Criteria:
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The bronchoscope is used to confirm or exclude a diagnosis in adult patients with airway complaints to identify a potential disease.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Perch, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
Provide data to Ambu A/S that can not be identified without the identification log.
2 years after study end
restricted access with user accounts to electronic data capture system
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006469 | Hemoptysis |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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total lesions detected by the core lab/ total lesions detected by Machine Learning (after training, using the test videos).
| 1 day |
| Number of sections and lesions detected by core lab and machine learning | Anatomical sections + lesions detected by core lab versus anatomical sections + lesions detected by machine learning | 1 day |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |