Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04604002
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2020-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Sponsor:
Heidelberg Engineering GmbH
Organization:
Study Overview
Official Title:
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Status:
COMPLETED
Status Verified Date:
2024-02
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:
OCTA
Brief Summary:
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
Detailed Description:
The objectives of this study are:
1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.
2\. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.
3\. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.
1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.
2\. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.
3\. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: