Actively Recruiting

Phase Not Applicable
Age: 50Years - 65Years
All Genders
ID06786793

Artificial Intelligence in Endoscopic Diagnosis of Colorectal Polyps A Prospective Randomized Study Evaluating AI Support During Colonoscopy

Led by Jagiellonian University · Updated on 2025-01-22

630

Participants Needed

2

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Colorectal cancer is the second most common cancer in European Union countries. Colonoscopy is the main method used to detect and prevent colorectal cancer by identifying and removing precancerous lesions like adenomas and serrated polyps. This study investigates how artificial intelligence (AI) might improve the detection rate of polyps and early colorectal cancer stages during colonoscopy procedures. The study uses an AI-assisted device called the Endo-Aid CADe system, which helps endoscopists by recognizing suspicious lesions in real time during colonoscopy. The system processes images from the colonoscopy and highlights potential polyps on the monitor to assist detection. Participants undergo standard outpatient colonoscopy with or without this AI device to compare outcomes. Participants are adults aged 50 to 65 scheduled for outpatient colonoscopy. During the study, researchers will monitor how often adenomas are detected using the AI system compared to usual care. The primary measurement is the adenoma detection rate during colonoscopy. The study excludes those with previous colonoscopy, colorectal surgery, certain inflammatory bowel diseases, or ongoing biological therapy. Consent to participate is required.

CONDITIONS

Official Title

Artificial Intelligence in Colonoscopy

Who Can Participate

Age: 50Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consent to participate in the study
  • Age between 50 and 65 years
  • Scheduled outpatient colonoscopy
Not Eligible

You will not qualify if you...

  • Previous colonoscopy
  • History of colorectal surgery
  • Ongoing biological therapy for any indication
  • Primary sclerosing cholangitis
  • Familial polyposis syndrome
  • Chronic diarrhea
  • Ulcerative colitis
  • Crohn's disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

MEDICINA Medical Center

Krakow, Lesser Poladn, Poland, 31559

Actively Recruiting

2

Brothers Hospitallers Medical Center, Hospital of St John of god in Krakow

Krakow, Lesser Polasd, Poland, 31061

Actively Recruiting

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Research Team

Z

Zofia Orzeszko, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Cost savings in colonoscopy with artificial intelligence-aided polyp diagnosis: an add-on analysis of a clinical trial (with video).

Yuichi Mori, Shin-Ei Kudo, James E East...

https://pubmed.ncbi.nlm.nih.gov/32240683

Artificial intelligence for polyp detection during colonoscopy: a systematic review and meta-analysis.

Ishita Barua, Daniela Guerrero Vinsard, Henriette C Jodal...

https://pubmed.ncbi.nlm.nih.gov/32557490