Adenoma ColonNCT05941689
Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System
A study testing AI-assisted colonoscopy in people with Adenoma Colon, run by Xiangya Hospital of Central South University at 2 sites in China.
Trial summary
This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma Colon
- What is being tested?
- AI-assisted colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,906 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jul 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:Patients who need to undergo colonoscopy. -
Exclusion Criteria:Patients with CRC, inflammatory bowel disease, previous colonic resection, and antithrombotic therapy precluding polyp resection were excluded.
-
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xiangya Hospital Central South University
Changsha, Hunan
Loudi Central Hospital
Loudi, Hunan
About this study
Official title: Research on the Auxiliary Diagnosis and Treatment System of Digestive Endoscopy Based on Artificial Intelligence: An Efficacy Study of Artificial Intelligence-assisted Colonic Polyp Detection System
This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.
- Conditions
- Adenoma Colon
- Being tested
- AI-assisted colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted colonoscopyDevice
AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted group | Experimental | Subjects in this group undergo AI-assisted colonoscopy. The AI-assisted system not only has the function of automatic polyp detection, but also has the function of colonoscopy quality control. Receives: Device: AI-assisted colonoscopy |
| control group | No intervention | Subjects in this group undergo routine colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
The proportion of patients with at least one histologically proven adenoma or carcinoma
Measured: up to 2months
withdrawal time compliance rate
The proportion of patients with clean withdrawal time >6min.
Measured: up to 2months
Secondary outcomes (3)
polyp detection rate
The proportion of patients with at least one polyp.
Measured: up to 2 months
adenoma per colonoscopy
The number of adenomas detected per colonoscopy
Measured: up to 2 months
polyp per colonoscopy
The number of polys detected per colonoscopy
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start25 Jul 2023
- Primary completion20 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma ColonStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,906 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaowei Liu, doctor, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941689
- Sponsor's protocol ID
- 202306499
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Auxiliary Diagnosis and Treatment System of Digestive Endoscopy Based on Artificial Intelligence: An Efficacy Study of Artificial Intelligence-assisted Colonic Polyp Detection System
- ClinicalTrials.gov ID
- NCT05941689
- Acronym / sponsor ID
- 202306499
- Conditions
- Adenoma Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,906 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 12 Jul 2023 (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.
This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted group | Experimental | Device: AI-assisted colonoscopySubjects in this group undergo AI-assisted colonoscopy. The AI-assisted system not only has the function of automatic polyp detection, but also has the function of colonoscopy quality control. |
| control group | No intervention | –Subjects in this group undergo routine colonoscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AI-assisted colonoscopyAI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically. | Device | AI-assisted group |
Primary outcome
adenoma detection rate
Time frame: up to 2months
The proportion of patients with at least one histologically proven adenoma or carcinoma
withdrawal time compliance rate
Time frame: up to 2months
The proportion of patients with clean withdrawal time >6min.
3 secondary outcomes
polyp detection rate
Time frame: up to 2 months
adenoma per colonoscopy
Time frame: up to 2 months
polyp per colonoscopy
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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. This study is not recruiting at the moment.
Xiaowei Liu, doctor principal investigator
Xiangya Hospital of Central South University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted colonoscopy in people with Adenoma Colon, run by Xiangya Hospital of Central South University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: up to 2months). The study lists 2 primary outcomes in all. 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 10 Oct 2023.