Computer Aided Detection of Polyps in the Colon
Trial ID: NCT03925337
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2019-05-07
Completion date: 2021-05-12
Sponsor: Beth Israel Deaconess Medical Center
Conditions: Polyp, Adenomatous; Colo-rectal Cancer
Interventions: Computer Aided Diagnostic Software
Locations: University of Chicago; Beth Israel Deaconess Medical Center; NYU Langone; Baylor College of Medicine
Countries: United States; United States; United States; United States
Enrollment: 234
Age range: 22 Years - None
Sex: ALL

Summary:
The purpose of this study is to examine the role of an automatic polyp detection software (henceforth referred to as the research software) as a support system during colonoscopy; a procedure during which a physician uses a colonoscope or scope, to look inside a patient's rectum and colon. The scope is a flexible tube with a camera-to see the lining of the colon. The research software is used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy.

The research software used in this study was programmed by a company in Shanghai, which develops artificial intelligence software for computer aided diagnostics.

The research software was developed using a large repository (database or databases) of polyp images where expert colonoscopists outlined polyps and suspicious lesions. The software was subsequently developed and validated using several databases of images and video to operate in near real-time or within minutes of photographing the tissue. It is intended to point out polyps and suspicious lesions on a separate screen that stands behind the primary monitor during colonoscopy. It is not expected to change the colonoscopy procedure in any way, and the physician will make the final determination on whether or not to biopsy or remove any lesion in the colon wall.

The research software will not record any video data during the colonoscopy procedure. In the future, this software may help gastroenterologists detect precancerous areas and decrease the incidence of colon cancer in the United States.

Eligibility criteria:
Inclusion Criteria:

* Patients age: ≥ 22 years
* Patients presenting for routine colonoscopy for screening and/or surveillance purposes.
* Willingness to undergo two withdrawals with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation
* Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion Criteria:

* Minors aged \< 22 years.
* People with diminished cognitive capacity
* Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active gastrointestinal bleed, referring collectively to the stomach and the small and large intestine).
* Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
* Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
* Patients with inflammatory bowel disease
* Patients with any polypoid/ulcerated lesion \> 2 cm concerning for invasive cancer on endoscopy
* Patients referred for endoscopic mucosal resection (EMR), which is a procedure to remove early-stage cancer and precancerous growths from the lining of the digestive tract.

Outcomes:
Adenoma Miss Rate (AMR)