Neoplasms

All Conditions

Symptoms and General Pathology

Adenocarcinoma

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ultivision Artificial Intelligence enhanced screening colonoscopies will be performed.

Screening colonoscopies without Artificial Intelligence enhancement will be performed.

Ultivision Artificial Intelligence Software

No Artificial Intelligence Software enhancement

Efren Rael, MD

Andrew Ninh

Robert Shaffer, MD

Josie Summers

Cristina Ortega

Taddese T Desta, MD

Prateek Sharma, MD

April Higbee

Louis Y Korman, MD

Ira Breite, MD

Natalie Neri, RN

Cortney Vazquez

Keith Friedenberg, MD

Dana Zahid

Joon Lee

Bezawit Tekola, MD

David Johnson, MD

Nalini Guda, MD

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.

Triple (Participant, Pathologist, Outcomes Assessor)

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

AIDA: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Artificial Intelligence (AI) Detection of Adenomas (AIDA) With Standard High Definition With Light in Screening Colonoscopy

Advanced adenoma detection rate (AADR) on SHDWLC using AI versus SHDWLC without AI.

Sessile serrated adenoma/polyp (SSA/P) detection rate on SHDWLC using AI versus SHDWLC without AI.

Polyp detection rate on SHDWLC using AI versus SHDWLC without AI.

Flat versus polypoid lesion detection rate on SHDWLC AI versus SHDWLC without AI.

Polyp location distribution on SHDWLC using AI versus SHDWLC without AI.

Surveillance-irrelevant lesion (SIL) and surveillance-relevant lesion (SRL) detection rates using SHDWLC AI versus SHDWLC without AI.

Recommended surveillance interval after using SHDWLC AI versus SHDWLC without AI.

Colonoscope withdrawal time using SHDWLC AI versus SHDWLC without AI.

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.

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.

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.

Spots Global Cancer Trial Database for no artificial intelligence software enhancement