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RecruitingNCT06406062Updated Apr 13, 2025

Artificial Intelligence-assisted System in Colonoscopy

An observational study in Adenoma Colon Polyp, sponsored by Renmin Hospital of Wuhan University. Recruiting at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by Renmin Hospital of Wuhan University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
7,500
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adenoma Colon Polyp

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03

In context

Polyps

312 studies on the registry are indexed under Polyps; 60 are open to participants now.

This study's planned enrollment of 7,500 is above the median of 209 across 101 observational studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

Renmin Hospital of Wuhan University is the lead sponsor of 86 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. have participated in other clinical trials, signed and are in the follow-up period of other clinical trials;
  2. known polyposis syndrome patients;
  3. patients with known IBD;
  4. patients considered by the investigators to be unsuitable or unable to undergo complete digestive endoscopy and related examinations;
  5. high-risk diseases or other special conditions considered by the investigator to be unsuitable for clinical trial participation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
7,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • AI-assisted group

    Group with AI assistance

    Device: ANDOANGEL

  • Control group

    Group without AI assistance

Interventions

  • DeviceANDOANGEL

    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.

06

What researchers measure

Primary outcomes

  1. Adenoma detection rate

    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

    Time frame: During Endoscopy procesure

Secondary outcomes

  1. Polyp detection rate

    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

    Time frame: During Endoscopy procesure

  2. Detection rate of serrated adenoma

    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

    Time frame: During Endoscopy procesure

  3. Average number of polyps per colonoscopy

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

    Time frame: During Endoscopy procesure

  4. Colonoscopy time

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

    Time frame: During Endoscopy procesure

  5. Proportion of over-speed frames

    Time frame: During Endoscopy procesure

07

Study locations

1 of 1 sites recruiting
  • Renmin Hospital of Wuhan Univercity
    Wuhan, Hubei 430060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2025, 19 months after the start.

Of 51 non-industry observational studies under Polyps, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 58. This study's planned 19 months is below that.

Counting every sponsor, half of 58 studies reached it within 30 months; a quarter within 11 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2024
First posted
May 9, 2024
StartActual
May 20, 2024
Primary completionEst.
Dec 30, 2025
CompletionEst.
Dec 30, 2025
Last update
Apr 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06406062
Lead sponsor
Renmin Hospital of Wuhan University
Responsible party
Sponsor
First posted
May 9, 2024
Start date
May 20, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Apr 13, 2025

Study contacts

Honggang Yu, Doctor
Contact
wjlnsm@163.com
18771146096

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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