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Computer-aided Detection During Screening Colonoscopy (Experts)

NCT04915833 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2022-03-31

No results posted yet for this study

Summary

Evaluation of the colonic mucosa with a high definition colonoscope (EPKi7010 video processor).

The endoscopy images will be seen on a 27inch, flat-panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) only by one expert endoscopist, randomly assigned.

The number, location, and polyps' features (Paris classification) will be recorded by the operator. If a polyp is detected, the endoscopist will remove the polyp endoscopically with a cold snare.

The same patient will be submitted to a second, the same session, computed aided real-time colonoscopy using the DISCOVERY, AI-assisted polyp detector. Colonoscopy will be performed by a same-level-of-expertise operator in comparison to the initial procedure. Any polyp or lesion detected with the AI system will be recorded and endoscopically removed and considered as a missed lesion from standard colonoscopy.

Conditions

  • Colorectal Neoplasms
  • Colon Polyp
  • Colon Adenoma

Interventions

DIAGNOSTIC_TEST

Standard high-definition colonoscopy

Evaluation of the colonic mucosa with a high definition colonoscope (EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) only by one expert endoscopist, randomly assigned. The number, location and polyps' features (Paris classification) will be recorded by the operator. If a polyp is detected, the endoscopist will remove the polyp endoscopically with a cold snare and forceps biopsy.

DIAGNOSTIC_TEST

Colonoscopy with real-time AI assisted automated polyp detection

The same patient will be submitted to a second, same session, computed aided real-time colonoscopy using the DISCOVERY, AI assisted polyp detector. Colonoscopy will be performed by a same-level-of-expertise operator in comparison to the initial procedure. Any polyp or lesion detected with the AI system will be recorded and endoscopically removed and considered as a missed lesion from standard colonoscopy.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda, MD FASGE · Ecuadorian Institute of Digestive Diseases

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2022-04-30
Completion
2022-06-28

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04915833 on ClinicalTrials.gov