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NCT Number: NCT06406062

Artificial Intelligence-assisted System in Colonoscopy

In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control.

This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control.

This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study.

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Key information

Conditions

Adenoma Colon Polyp

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renmin Hospital of Wuhan Univercity

Wuhan, Hubei, 430060, China

Location status: Recruiting

Location contact

Yu Honggang, Doctor

CONTACT

[email protected]

1371281899

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 50 years old;
  • required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy;
  • voluntarily sign informed consent;
  • Commitment to abide by the study procedures and cooperate with the implementation of the whole process of the study.

Exclusion criteria

  • have participated in other clinical trials, signed informed consent and are in the follow-up period of other clinical trials;
  • known polyposis syndrome patients;
  • patients with known IBD;
  • patients considered by the investigators to be unsuitable or unable to undergo complete digestive endoscopy and related examinations;
  • high-risk diseases or other special conditions considered by the investigator to be unsuitable for clinical trial participation.

Treatment and study plan

ANDOANGEL

Device

Polyps were identified by endoscopists assisted by an AI system: rectangular box marks; Monitoring of ileocecal position: whether blindness was reached was displayed in the lower left corner of the interface.

Mirror entry and exit time monitoring: the operation time is displayed in the upper left corner of the interface.

Colonoscopy withdrawal speed monitoring: the relative withdrawal speed was displayed on the left side of the interface.

Primary outcomes

  1. Adenoma detection rate

    Time frame: During Endoscopy procesure

    The numerator is the number of patients who had at least one adenoma on colonoscopy, and the denominator is the total number of patients who underwent colonoscopy

Secondary outcomes

  1. Polyp detection rate

    Time frame: During Endoscopy procesure

    The numerator is the number of patients who had at least one polyp on colonoscopy, and the denominator is the total number of patients who underwent colonoscopy

  2. Detection rate of serrated adenoma

    Time frame: During Endoscopy procesure

    The numerator is the number of patients who had at least one serrated adenoma on colonoscopy, and the denominator is the total number of patients who underwent colonoscopy

  3. Average number of polyps per colonoscopy

    Time frame: During Endoscopy procesure

    The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of colonoscopies

  4. Colonoscopy time

    Time frame: During Endoscopy procesure

    The pure negative time of the whole examination did not include the time of endoscopy entry and the time of biopsy

  5. Proportion of over-speed frames

    Time frame: During Endoscopy procesure

Study contacts

Contact information is provided by the study sponsor or research team.

Honggang Yu, Doctor

CONTACT

[email protected]

18771146096

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Obsevational Multicenter Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 9, 2024
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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