Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465797
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-10
Brief Title:
Observational Bronchoscopy Video Data Collection Study With Adult Patients
Sponsor:
Ambu AS
Organization:
Ambu AS
Study Overview
Official Title:
Collecting Imaging Data From Standard-of-care Bronchoscopies for AI-development a Prospective Non-interventional Study Using CE-marked Bronchoscopes
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None