Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305364
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-05
Brief Title:
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
Sponsor:
Jubaan Ltd
Organization:
Jubaan Ltd
Study Overview
Official Title:
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This is a prospective multicenter single-arm clinical investigation designed to evaluate the accuracy of the Gixam System in identifying subjects with colorectal adenomas compared to optical colonoscopy Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study Following an informed consent process images of the subjects tongue will be obtained with the Gixam System and a prediction score will be generated by the Gixam AI model Subjects will thereafter proceed to their SOC colonoscopy and the Gixam score will be compare with colonoscopy findings to evaluate its performance
Detailed Description:
None
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?:
None