Self ControlNCT05145712
Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas
A study testing Bowel readiness in people with Self Control and Prospective, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Self Control, Prospective, Interventional
- What is being tested?
- Bowel readiness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2021to 20 Mar 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 4 operators were included in this study, and the operating years of colonoscopy were ≥ 5 years, and the number of independent operating cases was ≥ 3000.
- Subjects who meet all of the following specific criteria will be considered for participation in the study:
- Male or female with age ≥ 45 years inclusive;
- Able to read, understand and sign informed consent;
- The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures.
Who cannot join
- Subjects who meet any of the following specific criteria will be refused to participate in the study:
- have a history of drug or alcohol abuse or psychological disorders within the last 5 years;
- Pregnant or lactating women;
- Patients with known multiple polyp syndrome;
- patients with known inflammatory bowel disease;
- known intestinal stenosis or space-occupying tumor;
Show all 11Show fewer
- known colon obstruction or perforation;
- patients with a history of colorectal surgery;
- Patients with previous history of allergy to pre-used spasmolysis;
- Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
- High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 027
Boru Chen, master, 15071054942, 2201017920@qq.com
About this study
Official title: A Single-center Study of an AI-assisted Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas Under Colonoscopy
To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.
- Conditions
- Self Control, Prospective, Interventional
- Being tested
- Bowel readiness
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel readinessDiagnostic test
During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing.
During the examination, the recorder should record the time points of the right colon, transverse colon, and left colon, as well as the time of irrigation.
If both are considered to be properly, then second colonoscopy was performed immediately.
If both results agree or either side agrees that the gut is not well prepared, the review will be carried out within a year
| Study group | Role | What they receive |
|---|---|---|
| Bowel readiness | Experimental | Not described Receives: Diagnostic Test: Bowel readiness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed detection rate of ≥5mm adenoma
(≥ 5mm adenoma missed rate, ≥ 5mm AMR) : Each patient will receive two colonoscopy examinations. The ≥ 5mm adenoma that were not detected in the first colonoscopy was define as missed ≥ 5mm adenoma. Numerator is the number of missed detection of ≥5mm adenomas during colonoscopy, and denominator is the total number of ≥ 5mm adenomas receiving colonoscopy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start21 Jul 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion20 Mar 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 Self ControlStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Honggang, Renmin Hospital of Wuhan University
- Investigators
- Honggang Yu, PhD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145712
- Sponsor's protocol ID
- EA-21-006
- Status last verified
- Nov 2021
- First submitted
- 20 Jul 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao L, Xiong H, Li Q, Wang W, Wu Z, Tan X, Luo C, You H, Zhang C, Zhang L, Lu Z, Yu H, Chen H. Validation of artificial intelligence-based bowel preparation assessment in screening colonoscopy (with video). Gastrointest Endosc. 2024 Oct;100(4):728-736.e9. doi: 10.1016/j.gie.2024.04.015. Epub 2024 Apr 16.
PubMed 38636818
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study of an AI-assisted Quantitative Bowel Readiness Assessment System in Predicting the Missed Detection Rate of Adenomas Under Colonoscopy
- ClinicalTrials.gov ID
- NCT05145712
- Acronym / sponsor ID
- EA-21-006
- Conditions
- Self Control, Prospective, Interventional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 6 Dec 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.
To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bowel readiness | Experimental | Diagnostic Test: Bowel readiness |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 4 operators were included in this study, and the operating years of colonoscopy were ≥ 5 years, and the number of independent operating cases was ≥ 3000.
- Subjects who meet all of the following specific criteria will be considered for participation in the study:
- Male or female with age ≥ 45 years inclusive;
- Able to read, understand and sign informed consent;
- The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures.
Key exclusion criteria (11 listed)
- Subjects who meet any of the following specific criteria will be refused to participate in the study:
- have a history of drug or alcohol abuse or psychological disorders within the last 5 years;
- Pregnant or lactating women;
- Patients with known multiple polyp syndrome;
- patients with known inflammatory bowel disease;
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 |
|---|---|---|
| Bowel readinessDuring the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing. During the examination, the recorder should record the time points of the right colon, transverse colon, and left colon, as well as the time of irrigation. If both are considered to be properly, then second colonoscopy was performed immediately. If both results agree or either side agrees that the gut is not well prepared, the review will be carried out within a year | Diagnostic test | Bowel readiness |
Primary outcome
Missed detection rate of ≥5mm adenoma
Time frame: 6 months
(≥ 5mm adenoma missed rate, ≥ 5mm AMR) : Each patient will receive two colonoscopy examinations. The ≥ 5mm adenoma that were not detected in the first colonoscopy was define as missed ≥ 5mm adenoma. Numerator is the number of missed detection of ≥5mm adenomas during colonoscopy, and denominator is the total number of ≥ 5mm adenomas receiving colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 38636818Yao L, Xiong H, Li Q, Wang W, Wu Z, Tan X, Luo C, You H, Zhang C, Zhang L, Lu Z, Yu H, Chen H. Validation of artificial intelligence-based bowel preparation assessment in screening colonoscopy (with video). Gastrointest Endosc. 2024 Oct;100(4):728-736.e9. doi: 10.1016/j.gie.2024.04.015. Epub 2024 Apr 16.
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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.
Honggang Yu, PhD principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel readiness in people with Self Control and Prospective, 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 5 inclusion and 11 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 6 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honggang Yu, PhD (13871281899, yuhonggang1969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Missed detection rate of ≥5mm adenoma (time frame: 6 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 NCT05145712, 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 6 Dec 2021.