ColonoscopyNCT04901130
Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection
A study of Colonoscopy, run by Shandong University at 6 sites in China.
Trial summary
The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,254 participants
- Where
- 6 sitesChina
- Study dates
- 27 May 2021to 31 Jan 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.
Who cannot join
- Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
- Patients with a history of colorectal surgery.
- Patients with a contraindication for biopsy.
- Patients with prior failed colonoscopy.
- Patients with known stenosis or obstruction.
- Patients in pregnancy or lactation phase.
- Patients refused to participate in the trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Binzhou Medical University Hospital
Binzhou, Shandong
Qiong Niu
Linyi People's Hospital
Dezhou, Shandong
Xiaodong Zhang
Central Hospital of Shengli Oilfield
Dongying, Shandong
Zhenqin Cui
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yanqing Li
Xiuli Zuo
The People's Hospital of Zhaoyuan City
Yantai, Shandong
Li Xing
Zibo Municipal Hospital
Zibo, Shandong
Weidong Zhao
About this study
Official title: Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection: a Multicenter Randomized Controlled Trial
The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.
Read the detailed description
We carried a multicenter randomised controlled trial to assess the performance of this system in quality control of real-time colonoscopy, including the adenoma detection rate (ADR), withdraw time, adequate bowel preparation rate and other indicators.
- Conditions
- Colonoscopy
- Being tested
- Computer-aided Real-time Automatic Quality Control System (AQCS)
- Keywords
- Artificial Intelligence, Colonoscopy, Quality Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-aided Real-time Automatic Quality Control System (AQCS)Device
Automatic quality-control system(AQCS), developed based on deep convolutional neural network (DCNN) models, could improve the colonoscopists' performance during withdrawal phase and significantly increase polyp and adenoma detection.
| Study group | Role | What they receive |
|---|---|---|
| AQCS-aided group | Experimental | Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS. Receives: Device: Computer-aided Real-time Automatic Quality Control System (AQCS) |
| Control group | No intervention | Patients in control group will go through conventional standard colonoscopy examination without the assistance of the AQCS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal adenoma detection rate (ADR)
The primary endpoint is the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected by colonoscopy.
Measured: 10 months
Secondary outcomes (4)
Colorectal polyp detection rate (PDR)
The polyp detection rate (PDR) is the proportion of patients having one or more polyps detected by colonoscopy.
Measured: 10 months
The mean number of adenomas detected per colonoscopy (APC)
The mean number of adenomas detected per colonoscopy in AQCS and control groups
Measured: 10 months
The mean number of polyps detected per colonoscopy (PPC)
The mean number of polyps detected per colonoscopy in AQCS and control groups
Measured: 10months
Withdrawl time
Withdrawl time is defined as the time taken to remove the colonoscope from the cecal pole minus the time of therapeutic interventions or biopsy, until the complete withdrawal of the colonoscope.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start27 May 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Binzhou Medical University, Shengli Oilfield Hospital, Linyi People's Hospital, Zibo Municipal Hospital, The People's Hospital of Zhaoyuan City
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD, Study chair, Qilu Hospital of Shandong UniversityXiuli Zuo, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901130
- Sponsor's protocol ID
- 2021SDU-QILU-066
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu J, Zhou R, Liu C, Liu H, Cui Z, Guo Z, Zhao W, Zhong X, Zhang X, Li J, Wang S, Xing L, Zhao Y, Ma R, Ni J, Li Z, Li Y, Zuo X. Automatic Quality Control System and Adenoma Detection Rates During Routine Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2457241. doi: 10.1001/jamanetworkopen.2024.57241.
PubMed 39883463
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04901130
- Acronym / sponsor ID
- 2021SDU-QILU-066
- Conditions
- Colonoscopy
- Keywords
- Artificial Intelligence, Colonoscopy, Quality Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,254 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Binzhou Medical University, Shengli Oilfield Hospital, Linyi People's Hospital, Zibo Municipal Hospital, The People's Hospital of Zhaoyuan City
- Study start
- 27 May 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 25 May 2021 (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.
The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.
Detailed description
We carried a multicenter randomised controlled trial to assess the performance of this system in quality control of real-time colonoscopy, including the adenoma detection rate (ADR), withdraw time, adequate bowel preparation rate and other indicators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQCS-aided group | Experimental | Device: Computer-aided Real-time Automatic Quality Control System (AQCS)Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS. |
| Control group | No intervention | –Patients in control group will go through conventional standard colonoscopy examination without the assistance of the AQCS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.
Key exclusion criteria (7 listed)
- Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
- Patients with a history of colorectal surgery.
- Patients with a contraindication for biopsy.
- Patients with prior failed colonoscopy.
- Patients with known stenosis or obstruction.
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 |
|---|---|---|
| Computer-aided Real-time Automatic Quality Control System (AQCS)Automatic quality-control system(AQCS), developed based on deep convolutional neural network (DCNN) models, could improve the colonoscopists' performance during withdrawal phase and significantly increase polyp and adenoma detection. | Device | AQCS-aided group |
Primary outcome
Colorectal adenoma detection rate (ADR)
Time frame: 10 months
The primary endpoint is the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected by colonoscopy.
4 secondary outcomes
Colorectal polyp detection rate (PDR)
Time frame: 10 months
The mean number of adenomas detected per colonoscopy (APC)
Time frame: 10 months
The mean number of polyps detected per colonoscopy (PPC)
Time frame: 10months
Withdrawl time
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Derived from this study: PubMed 39883463Liu J, Zhou R, Liu C, Liu H, Cui Z, Guo Z, Zhao W, Zhong X, Zhang X, Li J, Wang S, Xing L, Zhao Y, Ma R, Ni J, Li Z, Li Y, Zuo X. Automatic Quality Control System and Adenoma Detection Rates During Routine Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2457241. doi: 10.1001/jamanetworkopen.2024.57241.
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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.
Yanqing Li, PhD study chair
Qilu Hospital of Shandong University
Xiuli Zuo, PhD study chair
Qilu Hospital of Shandong University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Colonoscopy, run by Shandong University at 6 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?
The sponsor lists 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Li, PhD (18560086106, lizhenh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal adenoma detection rate (ADR) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901130, which also lists 1 linked publication.
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 25 May 2021.