Artificial IntelligenceNCT05751824
Evaluating the Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients
A study testing AI based automatic surveillance (AS) system (ENDOANGEL-AS) and Manually remind the patients to review. in people with Artificial Intelligence and Surveillance, run by Renmin Hospital of Wuhan University at 2 sites in China.
Trial summary
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence, Surveillance
- What is being tested?
- AI based automatic surveillance (AS) system (ENDOANGEL-AS) and Manually remind the patients to review.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 867 participants
- Where
- 2 sitesChina
- Study dates
- 26 Feb 2023to 31 Dec 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older who undergo colonoscopy.
Who cannot join
- 1)No pathological result.
- 2) No or invalid contact information.
- 3) The surveillance interval cannot be determined according to the surveillance guidelines, including poor bowel preparation, colorectal cancer or suspicious malignance, surgery or colorectal ESD history, those who fail to complete colonoscopy due to unbearable, pathological indications of not polyps, hamartoma or lymphoma polyps, history of ulcerative colitis, and so on.
- 4) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
- 5) Have drug or alcohol abuse or psychological disorder in the past five years.
- 6）Pregnancy.
- 7）Not suitable for recruitment after investigator evaluation because of other high-risk conditions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Guoen Lv, Doctor, 13536123479, lvrock@163.com
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Yu Honggang, Doctor, 13871281899, yuhonggang@whu.edu.cn
About this study
Official title: Evaluating the Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients: A Prospective, Multicenter Study
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups were compared.
- Conditions
- Artificial Intelligence, Surveillance
- Being tested
- AI based automatic surveillance (AS) system (ENDOANGEL-AS), Manually remind the patients to review.
- Keywords
- surveillance rate, automatic surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI based automatic surveillance (AS) system (ENDOANGEL-AS)Other
An automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.
Manually remind the patients to review.Other
Medical staff remind patients to review by telephone.
| Study group | Role | What they receive |
|---|---|---|
| With automatic surveillance system | Experimental | Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time. Receives: Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS) |
| With manual reminder | Active comparator | Patients were reminded of the surveillance time manually before the surveillance time. Receives: Other: Manually remind the patients to review. |
| Normal group | No intervention | The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
surveillance rate
The numerator is the number of patients with surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
Secondary outcomes (10)
Advance Surveillance Rate
The numerator is the number of patients with surveillance in advance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
On-time Surveillance Rate
The numerator is the number of patients with on-time surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
Delayed Surveillance Rate
The numerator is the number of patients with delayed surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.
Measured: From enrollment to study completion, assessed up to 3 years.
The accuracy of identifing post-polypectomy patients
The numerator is the number of patients correctly identified into post-polypectomy patients, and the denominator is the number of patients undergoing colonoscopy.
Measured: At the time of enrollment.
The accuracy of classifying risk levels
The numerator is the number of patients correctly classified by automated surveillance system, and the denominator is the number of all enrolled colorectal postpolypectomy patients.
Measured: At the time of enrollment.
The accuracy of assigning surveillance intervals
The numerator is the number of patients correctly assigned by automated surveillance system, and the denominator is the number of all enrolled colorectal postpolypectomy patients.
Measured: At the time of enrollment.
lesion progression rate
The numerator is the number of patients with lesion progression, and the denominator is the number of all surveillance colorectal postpolypectomy patients.
Measured: From enrollment to study completion, assessed up to 3 years.
lesion persistence rate
The numerator is the number of patients with lesion persistence, and the denominator is the number of all surveillance colorectal postpolypectomy patients.
Measured: From enrollment to study completion, assessed up to 3 years.
lesion regression rate
The numerator is the number of patients with lesion regression, and the denominator is the number of all surveillance colorectal postpolypectomy patients.
Measured: From enrollment to study completion, assessed up to 3 years.
The incidence rate of colorectal cancer
The numerator is the number of patients with colorectal cancer in surveillance colonoscopy, and the denominator is the number of all surveillance colorectal postpolypectomy patients.
Measured: From enrollment to study completion, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start26 Feb 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 867 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangmen Central Hospital
- Responsible party
- Sponsor
- Investigators
- Honggang Yu, phD, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751824
- Sponsor's protocol ID
- EA-23-01
- Status last verified
- Mar 2023
- First submitted
- 7 Nov 2022
- Last updated
- 9 Mar 2023
- Results posted
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients: A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT05751824
- Acronym / sponsor ID
- EA-23-01
- Conditions
- Artificial Intelligence, Surveillance
- Keywords
- surveillance rate, automatic surveillance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 867 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Jiangmen Central Hospital
- Study start
- 26 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Mar 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.
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups were compared.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| With automatic surveillance system | Experimental | Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time. |
| With manual reminder | Active comparator | Other: Manually remind the patients to review.Patients were reminded of the surveillance time manually before the surveillance time. |
| Normal group | No intervention | –The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female aged 18 years or older who undergo colonoscopy.
Key exclusion criteria (7 listed)
- 1)No pathological result.
- 2) No or invalid contact information.
- 3) The surveillance interval cannot be determined according to the surveillance guidelines, including poor bowel preparation, colorectal cancer or suspicious malignance, surgery or colorectal ESD history, those who fail to complete colonoscopy due to unbearable, pathological indications of not polyps, hamartoma or lymphoma polyps, history of ulcerative colitis, and so on.
- 4) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
- 5) Have drug or alcohol abuse or psychological disorder in the past five years.
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 based automatic surveillance (AS) system (ENDOANGEL-AS)An automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times. | Other | With automatic surveillance system |
| Manually remind the patients to review.Medical staff remind patients to review by telephone. | Other | With manual reminder |
Primary outcome
surveillance rate
Time frame: From enrollment to study completion, assessed up to 3 years.
The numerator is the number of patients with surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.
10 secondary outcomes
Advance Surveillance Rate
Time frame: From enrollment to study completion, assessed up to 3 years.
On-time Surveillance Rate
Time frame: From enrollment to study completion, assessed up to 3 years.
Delayed Surveillance Rate
Time frame: From enrollment to study completion, assessed up to 3 years.
The accuracy of identifing post-polypectomy patients
Time frame: At the time of enrollment.
The accuracy of classifying risk levels
Time frame: At the time of enrollment.
The accuracy of assigning surveillance intervals
Time frame: At the time of enrollment.
lesion progression rate
Time frame: From enrollment to study completion, assessed up to 3 years.
lesion persistence rate
Time frame: From enrollment to study completion, assessed up to 3 years.
lesion regression rate
Time frame: From enrollment to study completion, assessed up to 3 years.
The incidence rate of colorectal cancer
Time frame: From enrollment to study completion, assessed up to 3 years.
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 9 Mar 2023.
- 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.
Honggang Yu, phD principal investigator
Renmin Hospital of Wuhan 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 based automatic surveillance (AS) system (ENDOANGEL-AS) and Manually remind the patients to review. in people with Artificial Intelligence and Surveillance, run by Renmin Hospital of Wuhan 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?
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: opening soon, as of the sponsor's last update on 9 Mar 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?
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, 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?
surveillance rate (time frame: From enrollment to study completion, assessed up to 3 years.). 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 9 Mar 2023.