Actively Recruiting

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

Artificial Intelligence in Endoscopic Diagnosis of Colorectal Polyps: A Prospective Randomized Study

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

630

Participants Needed

2

Research Sites

8 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. The main way to detect and prevent colorectal cancer is through colonoscopy, which allows doctors to remove precancerous growths called adenomas and serrated polyps. This research aims to assess how using artificial intelligence (AI) during colonoscopy affects the detection rate of these polyps and early colorectal cancer stages, potentially improving screening quality and reducing cancer risk. Participants are randomly assigned to one of two groups: one group undergoes colonoscopy with the support of the ENDO-AID OIP-1 AI system that helps detect polyps by alerting the doctor in real-time, while the other group has colonoscopy without AI assistance. The AI system uses machine learning algorithms to identify suspicious lesions and mark them on the monitor during the procedure. This study compares the detection rates between these two approaches. During the colonoscopy, researchers measure the adenoma detection rate to evaluate effectiveness. They also assess how useful the AI is for both novice and experienced doctors, analyze the shape of detected polyps, and review the costs associated with using AI over about six months. Participants are followed through the procedure, and outcomes are monitored to understand the impact of AI on colonoscopy quality and colorectal cancer prevention.

CONDITIONS

Brief 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants undergo outpatient colonoscopy with or without the support of an artificial intelligence system for colorectal polyp detection.

1 procedure visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored for outcomes such as cost analysis and utility of artificial intelligence after the colonoscopy procedure.

Follow-up assessments as scheduled during the study period

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

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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