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.

Docbot, Inc.

Pathological Conditions, Anatomical

Routine Colonoscopy with the use of Skout

The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.

Computer Aided Detection device

Aasma Shaukat, MD, MPH

The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.

Computer Aided Detection of Polyps in Colonoscopy

Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy

The total number of adenomas detected divided by the total number of colonoscopies.

The total number of adenomas and serrated lesions detected divided by the total number of extractions.

The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected.

The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps.

The mean recommended timeframe for follow up colonoscopy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Colorectal Aden... Colorectal Poly... Colorectal Aden... Colorectal SSA	Ultivision Arti... No Artificial I...	45 Years - 75 Years	Docbot, Inc.
Computer Aided Detection of Polyps in Colonoscopy	NCT04754347	Colorectal Poly...	Computer Aided ...	40 Years -	Iterative Scopes, Inc

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