Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614491
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
SCOPE - Study of Classification for Observational Peristomal Evaluation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Observational Study for the Classification of Peristomal Skin Breakdown
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study to create an ostomy dataset and collect stoma photos to evaluate images digitally versus in-person ostomy skin assessment
Detailed Description:
The purpose of this study is to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment This resultant dataset will be used to evaluate the real-world use of the assessment tool and potentially to facilitate the development of an improved tool for assessing peristomal skin conditions in ostomates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None