Adenoma Colon PolypNCT06406062
Artificial Intelligence-assisted System in Colonoscopy
An observational study of Adenoma Colon Polyp, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Adenoma Colon Polyp
- What is being tested?
- ANDOANGEL
- Type of treatment
- Medical device
- How many people
- 7,500 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan Univercity
Wuhan, Hubei, 430060
Yu Honggang, Doctor, 1371281899, yuhonggang@whu.edu.cn
About this study
Official title: To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Obsevational Multicenter Study
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.
- Conditions
- Adenoma Colon Polyp
- Being tested
- ANDOANGEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANDOANGELDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted group | Group with AI assistance Receives: Device: ANDOANGEL | |
| Control group | Group without AI assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During Endoscopy procesure
Secondary outcomes (5)
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
Measured: During Endoscopy procesure
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
Measured: During Endoscopy procesure
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
Measured: During Endoscopy procesure
Colonoscopy time
The pure negative time of the whole examination did not include the time of endoscopy entry and the time of biopsy
Measured: During Endoscopy procesure
Proportion of over-speed frames
Measured: During Endoscopy procesure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start20 May 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma Colon PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406062
- Sponsor's protocol ID
- 2024K-K017
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Obsevational Multicenter Study
- ClinicalTrials.gov ID
- NCT06406062
- Acronym / sponsor ID
- 2024K-K017
- Conditions
- Adenoma Colon Polyp
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted group | – | Device: ANDOANGELGroup with AI assistance |
| Control group | – | –Group without AI assistance |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANDOANGELPolyps 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. | Device | AI-assisted group |
Primary outcome
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
5 secondary outcomes
Polyp detection rate
Time frame: During Endoscopy procesure
Detection rate of serrated adenoma
Time frame: During Endoscopy procesure
Average number of polyps per colonoscopy
Time frame: During Endoscopy procesure
Colonoscopy time
Time frame: During Endoscopy procesure
Proportion of over-speed frames
Time frame: During Endoscopy procesure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoma Colon Polyp, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Honggang Yu, Doctor (18771146096, wjlnsm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: During Endoscopy procesure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.