RITUAL Ultivision AI CADe Randomized Controlled Trial

Colon Adenoma Clinical Trial

— RITUAL  

Official title:

Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05732233
• Other study ID #: STF-2023-01
• Status: Terminated
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2023
• Source: Satisfai Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 45 to 75 years;

2. Screening or surveillance colonoscopy.

3. Iinformed consent

Exclusion Criteria:

1. Colorectal cancer;

2. Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;

3. Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;

4. Positive Fecal Immunochemical Test;

5. Use anti-platelet agents or anticoagulants that prevent polyps removal;

6. Colon resection, not including the appendix;

7. Subject is pregnant or lactating.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colon Adenoma
• Colonic Polyps
• Polyp of Colon

Intervention

Device:
• Ultivision AI
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) in adult patients undergoing colorectal cancer screening and surveillance examinations.

Locations

Country	Name	City	State
Canada	University of Montreal Research Center (CRCHUM)	Montréal (Québec)	Montreal
Italy	Humanitas Research Hospital	Milano
United States	UC Irvine	Irvine	California
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Satisfai Health, Inc.	Meditrial USA Inc.

Countries where clinical trial is conducted

United States,  Canada,  Italy, 

References & Publications (1)

Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.03 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma per Colonoscopy (APC)	Superiority of Ultivision-AI arm versus control arm. APC is defined as the total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.	During the procedure/surgery
Primary	Adenoma Per Extraction (APE).	Non inferiority of Ultivision-AI arm versus control arm. Where APE is the fraction of adenoma, sessile serrated lesions, and large (>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.	During the procedure/surgery

External Links

•   Meditrial Clinical Research Organization
•   Satisfai Health