Clinical trial NCT04196088: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Docbot, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 978
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: Polyp detection rate using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: Polyp location distribution using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: Colonoscope withdrawal time using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
timeFrame: through study completion, an average of 1 year
Locations:
city: Birmingham
country: United States
facility: Gastro Health
state: Alabama
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: Kansas City
country: United States
facility: Kansas City Veterans Administration
state: Kansas
city: Chevy Chase
country: United States
facility: Capital Digestive Care
state: Maryland
city: New York
country: United States
facility: East Side Endoscopy
state: New York
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC, Clinical Trials Network
state: Ohio
city: Fairfax
country: United States
facility: Verity Research Inc., Gastro Health
state: Virginia
city: Norfolk
country: United States
facility: Gastrointestinal & Liver Specialists of Tidewater, PLLC
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin GI Associates
state: Wisconsin
Study officials:
affiliation: Docbot, Inc.
name: Efren Rael, MD
role: STUDY_DIRECTOR
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