Colorectal Adenocarcinoma, Colorectal Adenoma, Colorectal Polyp, Colorectal SSA
Conditions
Keywords
screening colonoscopy, artificial intelligence, software as a medical device, adenoma detection rate, adenomas per endoscopy, mean adenomas per colonoscopy, colorectal cancer, medical device
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.
Interventions
DEVICEUltivision Artificial Intelligence Software
Screening Colonoscopy
DEVICENo Artificial Intelligence Software enhancement
Screening Colonoscopy
Sponsors
Docbot, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Triple (Participant, Pathologist, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | through study completion, an average of 1 year | Flat versus polypoid lesion detection rate on SHDWLC AI versus SHDWLC without AI. |
| Polyp location distribution 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 location distribution on SHDWLC using AI versus SHDWLC without AI. |
| 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 | Advanced adenoma detection rate (AADR) on SHDWLC using AI versus SHDWLC without AI. |
| 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. | through study completion, an average of 1 year | Recommended surveillance interval after using SHDWLC AI versus SHDWLC without AI. |
| Colonoscope withdrawal time 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 | Colonoscope withdrawal time using SHDWLC AI versus SHDWLC without AI. |
| 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. | 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. |
| 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 | Sessile serrated adenoma/polyp (SSA/P) detection rate on SHDWLC using AI versus SHDWLC without AI. |
| 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 | Polyp detection rate on SHDWLC using AI versus SHDWLC without AI. |
Countries
United States
Contacts
Primary ContactEfren Rael, MD
Backup ContactAndrew Ninh
Outcome results
None listed