RITUAL Ultivision AI CADe Randomized Controlled Trial

Satisfai Health

Status: Terminated

Conditions: Colon Adenoma; Polyp of Colon; Adenoma Colon

Treatments: Device: Ultivision AI

Study type: Interventional

Funder types: Industry

Identifiers

NCT05732233

STF-2023-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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137 participants in 2 patient groups

Ultivision AI colonoscopy (CADe Arm)

Experimental group

Description:

Ultivision AI is used to aid in real-time detection of adenomas.

Treatment:

Device: Ultivision AI

Standard colonoscopy (Control Arm)

Active Comparator group

Description:

Patients will undergo standard colonoscopy without AI.

Treatment:

Device: Ultivision AI