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 | Unknown DMC FDA Device

• 1 other identifier: Docbot AIDA: Ultivision_002
• Study Type: interventional
• Target: 978
• Locations: 1 country
• Sites: 9

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.

Conditions

Colorectal Adenoma; Colorectal Polyp; Colorectal Adenocarcinoma; Colorectal SSA

Keywords

screening colonoscopy; artificial intelligence; software as a medical device; adenoma detection rate; adenomas per endoscopy; mean adenomas per colonoscopy; colorectal cancer; medical device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Other Outcomes (8)

• 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.

  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.

  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.

  through study completion, an average of 1 year

Study Arms (2)

Ultivision AI Software enhanced screening colonoscopy

ACTIVE COMPARATOR

Ultivision Artificial Intelligence enhanced screening colonoscopies will be performed.

Device: Ultivision Artificial Intelligence Software

No AI enhancement screening colonoscopy

PLACEBO COMPARATOR

Screening colonoscopies without Artificial Intelligence enhancement will be performed.

Device: No Artificial Intelligence Software enhancement

Interventions

Ultivision Artificial Intelligence Software DEVICE

Screening Colonoscopy

Ultivision AI Software enhanced screening colonoscopy

No Artificial Intelligence Software enhancement DEVICE

Screening Colonoscopy

No AI enhancement screening colonoscopy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Docbot, Inc.: lead

Study Sites (9)

Gastro Health

Birmingham, Alabama, 35209, United States

RECRUITING

Precision Research Institute

San Diego, California, 92114, United States

RECRUITING

Kansas City Veterans Administration

Kansas City, Kansas, 66103, United States

RECRUITING

Capital Digestive Care

Chevy Chase, Maryland, 20815, United States

RECRUITING

East Side Endoscopy

New York, New York, 10010, United States

RECRUITING

Great Lakes Gastroenterology Research, LLC, Clinical Trials Network

Mentor, Ohio, 44060, United States

RECRUITING

Verity Research Inc., Gastro Health

Fairfax, Virginia, 22031, United States

RECRUITING

Gastrointestinal & Liver Specialists of Tidewater, PLLC

Norfolk, Virginia, 23502, United States

RECRUITING

Wisconsin GI Associates

Milwaukee, Wisconsin, 53215, United States

RECRUITING

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Efren Rael, MD

  Docbot, Inc.

  STUDY DIRECTOR

Central Study Contacts

Efren Rael, MD

CONTACT

7179030979; efren.rael@docbot.ai

Andrew Ninh

CONTACT

7147166674; andrew.ninh@docbot.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Pathologist, Outcomes Assessor)
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: June 11, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)