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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Adenoma, Colorectal Polyp, Colorectal Adenocarcinoma, Colorectal SSA

Intervention / Treatment
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* Device: Ultivision Artificial Intelligence Software
* Device: No Artificial Intelligence Software enhancement


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria. Average risk asymptomatic subjects undergoing a first colonoscopy (screening) or screening colonoscopy at least 10 years after prior colonoscopy. Aged 45 years to aged 75 years at the time of enrollment. Capable of providing written informed consent and willing and able to adhere to all protocol requirements, and/or the subject's legally acceptable representative(s) capable of providing written informed consent. Primary Exclusion Criteria. History of any colorectal cancer or colon adenomas. History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis. Family history of colon cancer or precancerous colon polyp in a first degree relative before age 50. Polyposis syndromes including Familial Adenomatous Polyposis, Cowden syndrome, Lynch syndrome, Peutz-Jeghers syndrome, MUTYH Associated Polyposis, Familial Colorectal Cancer Type X. Surveillance, therapeutic, preoperative, or diagnostic colonoscopy. Colonoscopy for work-up of abdominal or pelvic symptoms including abdominal pain, flank pain, pelvic pain, subject report of altered stool, subject report of anemia within the past 12 months, subject report of gastrointestinal bleeding including bright red blood per rectum or tarry stools, constipation, diarrhea, subject reported history of abdominal or pelvic mass, subject report of unintentional weight loss. Workup or referral to diagnose or evaluate abnormal imaging of the abdomen or pelvis. Positive Fecal Immunochemical Test history. Severe co-mobordity, including end-stage cardiovascular, pulmonary, liver, or renal disease. History of colon resection, not including the appendix. Currently receiving a therapy not permitted during the trial, as defined in Section 8.3. Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the trial. Enrolled subjects will be eligible for Post-procedure Periods if their colonoscopy meets the following criteria: Adequate bowel preparation score per the Boston Bowel Preparation Scoring System (BBPS) > or equal to 2 in all colonic segments. Colonoscopies with successful cecal intubation. Colonoscopies with withdrawal times of at least 6 minutes.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultivision AI Software enhanced screening colonoscopy<br>Ultivision Artificial Intelligence enhanced screening colonoscopies will be performed. | Device: Ultivision Artificial Intelligence Software<br>* Screening Colonoscopy<br>|
| Placebo Comparator: No AI enhancement screening colonoscopy<br>Screening colonoscopies without Artificial Intelligence enhancement will be performed. | Device: No Artificial Intelligence Software enhancement<br>* Screening Colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | through study completion, an average of 1 year | 
| 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. | 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. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening colonoscopy, artificial intelligence, software as a medical device, adenoma detection rate, adenomas per endoscopy, mean adenomas per colonoscopy, colorectal cancer, medical device