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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultivision AI Software enhanced screening colonoscopy | Active Comparator | Ultivision Artificial Intelligence enhanced screening colonoscopies will be performed. |
|
| No AI enhancement screening colonoscopy | Placebo Comparator | Screening colonoscopies without Artificial Intelligence enhancement will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultivision Artificial Intelligence Software | Device | Screening Colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Primary Inclusion Criteria.
Primary Exclusion Criteria.
Enrolled subjects will be eligible for Post-procedure Periods if their colonoscopy meets the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Efren Rael, MD | Contact | 7179030979 | efren.rael@docbot.ai | |
| Andrew Ninh | Contact | 7147166674 | andrew.ninh@docbot.ai |
| Name | Affiliation | Role |
|---|---|---|
| Efren Rael, MD | Docbot, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastro Health | Recruiting | Birmingham | Alabama | 35209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22356322 | Background | Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370. | |
| 21200035 | Background |
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Triple (Participant, Pathologist, Outcomes Assessor)
| No Artificial Intelligence Software enhancement | Device | Screening Colonoscopy |
|
| 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. |
Sessile serrated adenoma/polyp (SSA/P) detection rate on SHDWLC using AI versus 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. | Polyp detection rate on SHDWLC using AI versus SHDWLC without AI. | through study completion, an average of 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Precision Research Institute | Recruiting | San Diego | California | 92114 | United States |
|
| Kansas City Veterans Administration | Recruiting | Kansas City | Kansas | 66103 | United States |
|
| Capital Digestive Care | Recruiting | Chevy Chase | Maryland | 20815 | United States |
|
| East Side Endoscopy | Recruiting | New York | New York | 10010 | United States |
|
| Great Lakes Gastroenterology Research, LLC, Clinical Trials Network | Recruiting | Mentor | Ohio | 44060 | United States |
|
| Verity Research Inc., Gastro Health | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| Gastrointestinal & Liver Specialists of Tidewater, PLLC | Recruiting | Norfolk | Virginia | 23502 | United States |
|
| Wisconsin GI Associates | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
|
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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