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To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age

NCT04196088 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 978

Last updated 2021-03-19

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.

Conditions

  • Colorectal Adenoma
  • Colorectal Polyp
  • Colorectal Adenocarcinoma
  • Colorectal SSA

Interventions

DEVICE

Ultivision Artificial Intelligence Software

Screening Colonoscopy

DEVICE

No Artificial Intelligence Software enhancement

Screening Colonoscopy

Sponsors & Collaborators

  • Docbot, Inc.

    lead INDUSTRY

Principal Investigators

  • Efren Rael, MD · Docbot, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-11
Primary Completion
2021-11-30
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

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 NCT04196088 on ClinicalTrials.gov