Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 11:18 AM
Study NCT ID:
NCT05732233
Status:
TERMINATED
Last Update Posted:
2024-05-13
First Post:
2023-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RITUAL Ultivision AI CADe Randomized Controlled Trial
Sponsor:
Satisfai Health, Inc.
Organization:
Study Overview
Official Title:
Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RITUAL
Brief Summary:
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).
Ultivision AI CADe is indicated for white light colonoscopy only.
Ultivision AI CADe is indicated for white light colonoscopy only.
Detailed Description:
Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).
The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.
The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.
Study Oversight
Has Oversight DMC:
False
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?: