NCT04777019

Brief Summary

Computer aided detection (CADe) algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy. The aim of this study was to investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls from two different institutes.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

February 2, 2021

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls

    The video library was developed during screening and surveillance colonoscopy and included details on polyp size, location, morphology, overall Boston bowel preparation score (BBPS) and segmental BBPS. Each video segments ranged from 35 seconds to 75 seconds. Before inclusion, each video was evaluated by 3 expert endoscopists individually to assess overall quality of the video. Quality of video was assessed based on pixel resolution and aspect ratio, bowel preparation, overall speed of withdrawal, colon distension, and adequate mucosal exposure. If the video was deemed of adequate quality by at least 2 endoscopists, it was included in the study cohort.

    3 years

Interventions

Not applicable since not an intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Currently, the most commonly used quality marker in conventional colonoscopy (CC) is adenoma detection rate (ADR), which has been shown to inversely correlate with the incidence of CRC.3 Although colonoscopy is generally considered to be the most accurate screening modality, a substantial number of polyps are still missed. Hence population scheduled for a colonoscopy at either of the institution were part of the project.

You may qualify if:

  • Patients scheduled for a regular or screening colonoscopy at the institution as standard of care.
  • Over 18 years of age

You may not qualify if:

  • Pregnant patients
  • Inmate or prisoners
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2021

First Posted

March 2, 2021

Study Start

June 7, 2020

Primary Completion

June 7, 2023

Study Completion

June 6, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08