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RITUAL Ultivision AI CADe Randomized Controlled Trial

NCT05732233 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2024-05-13

No results posted yet for this study

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.

Conditions

  • Colon Adenoma
  • Polyp of Colon
  • Adenoma Colon

Interventions

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.

Sponsors & Collaborators

  • Meditrial USA Inc.

    collaborator INDUSTRY

  • Satisfai Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2024-02-23
Completion
2024-02-23
FDA Device
Yes

Countries

  • United States
  • Canada
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05732233 on ClinicalTrials.gov