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)

March 17, 2021 updated by: Docbot, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

978

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • California
      • San Diego, California, United States, 92114
        • Recruiting
        • Precision Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Taddese T Desta, MD
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Recruiting
        • Kansas City Veterans Administration
        • Contact:
        • Contact:
    • Maryland
    • New York
      • New York, New York, United States, 10010
        • Recruiting
        • East Side Endoscopy
        • Contact:
          • Ira Breite, MD
          • Phone Number: 212-375-1065
        • Contact:
          • Natalie Neri, RN
          • Phone Number: 212-375-1065
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • Great Lakes Gastroenterology Research, LLC, Clinical Trials Network
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Verity Research Inc., Gastro Health
        • Principal Investigator:
          • Bezawit Tekola, MD
        • Contact:
        • Contact:
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Gastrointestinal & Liver Specialists of Tidewater, PLLC
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Wisconsin GI Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Primary Inclusion Criteria.

  1. Average risk asymptomatic subjects undergoing a first colonoscopy (screening) or screening colonoscopy at least 10 years after prior colonoscopy.
  2. Aged 45 years to aged 75 years at the time of enrollment.
  3. 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.

  1. History of any colorectal cancer or colon adenomas.
  2. History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis.
  3. Family history of colon cancer or precancerous colon polyp in a first degree relative before age 50.
  4. Polyposis syndromes including Familial Adenomatous Polyposis, Cowden syndrome, Lynch syndrome, Peutz-Jeghers syndrome, MUTYH Associated Polyposis, Familial Colorectal Cancer Type X.
  5. Surveillance, therapeutic, preoperative, or diagnostic colonoscopy.
  6. 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.
  7. Workup or referral to diagnose or evaluate abnormal imaging of the abdomen or pelvis.
  8. Positive Fecal Immunochemical Test history.
  9. Severe co-mobordity, including end-stage cardiovascular, pulmonary, liver, or renal disease.
  10. History of colon resection, not including the appendix.
  11. Currently receiving a therapy not permitted during the trial, as defined in Section 8.3.
  12. 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:

  1. Adequate bowel preparation score per the Boston Bowel Preparation Scoring System (BBPS) > or equal to 2 in all colonic segments.
  2. Colonoscopies with successful cecal intubation.
  3. Colonoscopies with withdrawal times of at least 6 minutes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced adenoma detection rate (AADR) using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Advanced adenoma detection rate (AADR) on SHDWLC using AI versus SHDWLC without AI.
through study completion, an average of 1 year
Sessile serrated adenoma/polyp (SSA/P) detection rate using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Sessile serrated adenoma/polyp (SSA/P) detection rate on SHDWLC using AI versus SHDWLC without AI.
through study completion, an average of 1 year
Polyp detection rate using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Polyp detection rate on SHDWLC using AI versus SHDWLC without AI.
through study completion, an average of 1 year
Flat versus polypoid lesion detection rate using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Flat versus polypoid lesion detection rate on SHDWLC AI versus SHDWLC without AI.
through study completion, an average of 1 year
Polyp location distribution using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Polyp location distribution on SHDWLC using AI versus SHDWLC without AI.
through study completion, an average of 1 year
Surveillance-irrelevant lesion (SIL) and surveillance-relevant lesion (SRL) detection rate using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Surveillance-irrelevant lesion (SIL) and surveillance-relevant lesion (SRL) detection rates using SHDWLC AI versus SHDWLC without AI.
through study completion, an average of 1 year
Post colonoscopy recommended surveillance follow-up interval using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Recommended surveillance interval after using SHDWLC AI versus SHDWLC without AI.
through study completion, an average of 1 year
Colonoscope withdrawal time using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
Time Frame: through study completion, an average of 1 year
Colonoscope withdrawal time using SHDWLC AI versus SHDWLC without AI.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Docbot, Inc.

Investigators

  • Study Director: Efren Rael, MD, Docbot, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Docbot AIDA: Ultivision_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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