Back to resultsRITUAL Ultivision AI CADe Randomized Controlled Trial (RITUAL)
Primary Purpose
Colon Adenoma, Polyp of Colon, Adenoma Colon
Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ultivision AI
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Adenoma focused on measuring Screening, Surveillance, Artificial Intelligence, Colonoscopy
Eligibility Criteria
Inclusion Criteria: Age 45 to 75 years; Screening or surveillance colonoscopy. Iinformed consent Exclusion Criteria: Colorectal cancer; Inflammatory bowel disease, including Crohn's disease or ulcerative colitis; Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X; Positive Fecal Immunochemical Test; Use anti-platelet agents or anticoagulants that prevent polyps removal; Colon resection, not including the appendix; Subject is pregnant or lactating.
Sites / Locations
- UC Irvine
- University of Kansas Medical Center
- University of Montreal Research Center (CRCHUM)
- Humanitas Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultivision AI colonoscopy (CADe Arm)
Standard colonoscopy (Control Arm)
Arm Description
Ultivision AI is used to aid in real-time detection of adenomas.
Patients will undergo standard colonoscopy without AI.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05732233
First Posted
February 7, 2023
Last Updated
February 17, 2023
Sponsor
Satisfai Health, Inc.
Collaborators
Meditrial USA Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05732233
Brief Title
RITUAL Ultivision AI CADe Randomized Controlled Trial
Acronym
RITUAL
Official Title
Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 3, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Satisfai Health, Inc.
Collaborators
Meditrial USA Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma, Polyp of Colon, Adenoma Colon
Keywords
Screening, Surveillance, Artificial Intelligence, Colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel trial design
Masking
Outcomes Assessor
Masking Description
Pathologist is blind to group assignment
Allocation
Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultivision AI colonoscopy (CADe Arm)
Arm Type
Experimental
Arm Description
Ultivision AI is used to aid in real-time detection of adenomas.
Arm Title
Standard colonoscopy (Control Arm)
Arm Type
Active Comparator
Arm Description
Patients will undergo standard colonoscopy without AI.
Intervention Type
Device
Intervention Name(s)
Ultivision AI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adenoma per Colonoscopy (APC)
Description
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.
Time Frame
During the procedure/surgery
Title
Adenoma Per Extraction (APE).
Description
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.
Time Frame
During the procedure/surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 45 to 75 years;
Screening or surveillance colonoscopy.
Iinformed consent
Exclusion Criteria:
Colorectal cancer;
Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;
Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;
Positive Fecal Immunochemical Test;
Use anti-platelet agents or anticoagulants that prevent polyps removal;
Colon resection, not including the appendix;
Subject is pregnant or lactating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Tocchi, MD,PhD
Phone
+1 646 933 1025
Email
m.tocchi@meditrial.net
Facility Information:
Facility Name
UC Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Karnes
Email
karnesw@hs.uci.edu
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Rastogi, MD, FASGE
Facility Name
University of Montreal Research Center (CRCHUM)
City
Montréal (Québec)
State/Province
Montreal
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel von Renteln
Email
danielrenteln@gmail.com
Facility Name
Humanitas Research Hospital
City
Milano
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici
Email
alessandro.repici@hunimed.eu
First Name & Middle Initial & Last Name & Degree
Cesare Hassan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29928897
Citation
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.2018.06.037. Epub 2018 Jun 18.
Results Reference
result
Links:
URL
https://satisfai.health/
Description
Satisfai Health
URL
https://www.meditrial.net/
Description
Meditrial Clinical Research Organization
Learn more about this trial
RITUAL Ultivision AI CADe Randomized Controlled Trial
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