Purpose

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

Eligibility

Eligible Ages
Between 45 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Triple (Participant, Pathologist, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Kansas City Veterans Administration
Kansas City, Kansas 66103
Contact:
Prateek Sharma, MD
816-861-4700
psharma@kumc.edu

More Details

Status
Unknown status
Sponsor
Docbot, Inc.

Study Contact

Efren Rael, MD
7179030979
efren.rael@docbot.ai

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.