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

Colorectal Adenoma Clinical Trial

— AIDA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04196088
• Other study ID #: Docbot AIDA: Ultivision_002
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Docbot, Inc.
• Contact: Efren Rael, MD
• Phone: 7179030979
• Email: efren.rael[@]docbot.ai
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 978
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenocarcinoma
• Colorectal Adenoma
• Colorectal Polyp
• Colorectal SSA

Intervention

Device:
• Ultivision Artificial Intelligence Software
Screening Colonoscopy
• No Artificial Intelligence Software enhancement
Screening Colonoscopy

Locations

Country	Name	City	State
United States	Gastro Health	Birmingham	Alabama
United States	Capital Digestive Care	Chevy Chase	Maryland
United States	Verity Research Inc., Gastro Health	Fairfax	Virginia
United States	Kansas City Veterans Administration	Kansas City	Kansas
United States	Great Lakes Gastroenterology Research, LLC, Clinical Trials Network	Mentor	Ohio
United States	Wisconsin GI Associates	Milwaukee	Wisconsin
United States	East Side Endoscopy	New York	New York
United States	Gastrointestinal & Liver Specialists of Tidewater, PLLC	Norfolk	Virginia
United States	Precision Research Institute	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Docbot, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Advanced adenoma detection rate (AADR) on SHDWLC using AI versus SHDWLC without AI.	through study completion, an average of 1 year
Other	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.	Sessile serrated adenoma/polyp (SSA/P) detection rate on SHDWLC using AI versus SHDWLC without AI.	through study completion, an average of 1 year
Other	Polyp detection rate using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.	Polyp detection rate on SHDWLC using AI versus SHDWLC without AI.	through study completion, an average of 1 year
Other	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.	Flat versus polypoid lesion detection rate on SHDWLC AI versus SHDWLC without AI.	through study completion, an average of 1 year
Other	Polyp location distribution using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.	Polyp location distribution on SHDWLC using AI versus SHDWLC without AI.	through study completion, an average of 1 year
Other	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.	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
Other	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.	Recommended surveillance interval after using SHDWLC AI versus SHDWLC without AI.	through study completion, an average of 1 year
Other	Colonoscope withdrawal time using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.	Colonoscope withdrawal time using SHDWLC AI versus SHDWLC without AI.	through study completion, an average of 1 year
Primary	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
Primary	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	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