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

Not Applicable

• Conditions: Colorectal Adenoma; Colorectal Polyp; Colorectal Adenocarcinoma; Colorectal SSA
• Interventions: Device: Ultivision Artificial Intelligence Software; Device: No Artificial Intelligence Software enhancement

• Registration Number: NCT04196088
• Lead Sponsor: Docbot, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2020-06-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 978

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultivision AI Software enhanced screening colonoscopy	Ultivision Artificial Intelligence Software	Ultivision Artificial Intelligence enhanced screening colonoscopies will be performed.
No AI enhancement screening colonoscopy	No Artificial Intelligence Software enhancement	Screening colonoscopies without Artificial Intelligence enhancement will be performed.

Primary Outcome Measures

Name	Time	Method
Overall adenomas per extraction, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard hiigh definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.	through study completion, an average of 1 year	The primary safety endpoint is the adenomas per extraction per colonoscopy procedure (APE), as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus SHDWLC without AI.
Overall adenoma detection, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.	through study completion, an average of 1 year	The primary efficacy endpoint is the mean adenomas per colonoscopy procedure (MAP) detection, as defined by the protocol, with Ultivision AI software enhancement to screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.	through study completion, an average of 1 year	The secondary efficacy endpoint is the adenoma detection rate (ADR) defined as the ratio of screening colonoscopies with at least one adenoma, as defined by the protocol, detected divided by the total number of screening SHDWLC performed with Ultivision AI versus screening SHDWLC performed without AI.

Trial Locations

Locations (9)

Gastrointestinal & Liver Specialists of Tidewater, PLLC; 🇺🇸 Norfolk, Virginia, United States

Great Lakes Gastroenterology Research, LLC, Clinical Trials Network; 🇺🇸 Mentor, Ohio, United States

East Side Endoscopy; 🇺🇸 New York, New York, United States

Capital Digestive Care; 🇺🇸 Chevy Chase, Maryland, United States

Kansas City Veterans Administration; 🇺🇸 Kansas City, Kansas, United States

Gastro Health; 🇺🇸 Birmingham, Alabama, United States

Precision Research Institute; 🇺🇸 San Diego, California, United States

Verity Research Inc., Gastro Health; 🇺🇸 Fairfax, Virginia, United States

Wisconsin GI Associates; 🇺🇸 Milwaukee, Wisconsin, United States