NCT03925337

Computer Aided Detection of Polyps in the Colon

Completed NA Last updated 20 July 2021

What this trial tests

NA trial testing Computer Aided Diagnostic Software in Polyp, Adenomatous in 234 participants. Completed in 12 May 2021.

Timeline

7 May 2019

Primary endpoint
24 November 2020

12 May 2021

Quick facts

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	234
Start date	7 May 2019
Primary completion	24 November 2020
Estimated completion	12 May 2021
Sites	4 locations across United States

Drugs / interventions tested

• Computer Aided Diagnostic Software

Conditions studied

• Polyp, Adenomatous — all drugs for Polyp, Adenomatous →
• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →

Sponsor

Beth Israel Deaconess Medical Center

Who can join

22 and older, any sex, with Polyp, Adenomatous or Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Artificial Intelligence in Oncology: A 10-Year ClinicalTrials.gov-Based Analysis Across the Cancer Control Continuum.
   Verma H, Mistry S, Jayam KV, Shrestha P, et al · · 2025 · PMID 41228330 · DOI 10.3390/cancers17213537