Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:37 AM
Study NCT ID:
NCT05006092
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2021-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)
Sponsor:
Wuerzburg University Hospital
Organization:
Study Overview
Official Title:
Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort
Status:
COMPLETED
Status Verified Date:
2023-04
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:
SMARTIE
Brief Summary:
Evaluation of an artificial intelligence system for polyp detection (CADe)
Detailed Description:
We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.
Study Oversight
Has Oversight DMC:
False
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?: