A Randomized Controlled Multicenter Study of Artificial Intelligence Assisted Digestive Endoscopy

October 20, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Digestive endoscopy center of the second affiliated hospital of medical college of zhejiang university and engineers of naki medical co., ltd. in Hong Kong independently developed an ai-assisted diagnostic model of digestive endoscopy in the early stage, namely the deep learning model.The deep learning model through the early stage of the study, is able to identify lesions of digest tract.The sensitivity for the diagnosis of some diseases, such as colon polyps, is 99%. On the one hand, this auxiliary diagnostic model can guide endoscopic examination for beginners; on the other hand, it can improve the detection rate of lesions and reduce the rate of missed diagnosis; on the other hand, the overall operating efficiency of the endoscopic center is improved, which is conducive to the quality control of endoscopic examination. Now the AI-assisted diagnostic model has been further improved, and it is planned to carry out further clinical verification in the digestive endoscopy center of our hospital. It is connected to the endoscopic system of our hospital and used simultaneously with the existing image-text system of endoscopy to compare the practicability, sensitivity and specificity of AI-assisted diagnosis model in the diagnosis of digestive tract diseases, and focus on the quality control of endoscopic examination.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Digestive endoscopy center of the second affiliated hospital of medical college of zhejiang university and engineers of naki medical co., ltd. in Hong Kong independently developed an ai-assisted diagnostic model of digestive endoscopy in the early stage, namely the deep learning model。The deep learning model through the early stage of the study, is able to identify lesions of colon polyps, colorectal cancer, colorectal apophysis lesions, colonic diverticulum, ulcerative colitis, gastric ulcer, gastric polyps, submucosal uplift, reflux esophagitis, esophageal ulcer, esophageal polyp, esophageal erosion, esophageal ectopic gastric mucosa and esophagus varicosity, esophageal cancer, esophageal papilloma, etc.The sensitivity for the diagnosis of some diseases, such as colon polyps, is 99%. On the one hand, this auxiliary diagnostic model can guide endoscopic examination for beginners; on the other hand, it can improve the detection rate of lesions and reduce the rate of missed diagnosis; on the other hand, the overall operating efficiency of the endoscopic center is improved, which is conducive to the quality control of endoscopic examination. Now the AI-assisted diagnostic model has been further improved, and it is planned to carry out further clinical verification in the digestive endoscopy center of our hospital. It is connected to the endoscopic system of our hospital and used simultaneously with the existing image-text system of endoscopy to compare the practicability, sensitivity and specificity of AI-assisted diagnosis model in the diagnosis of digestive tract diseases, and focus on the quality control of endoscopic examination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Wang J An, Dr
  • Phone Number: 057187783759 057187783759
  • Email: HREC2013@126.com

Study Contact Backup

  • Name: Cai J Ting, Dr
  • Phone Number: 15267019902 15267019902
  • Email: 1173920428@qq.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Cai J Ting
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent painless gastroenteroscopy at the endoscopy center from September 2019 to August 2021

Description

Inclusion Criteria:

  • Voluntarily sign the informed consent for this study
  • Stable vital signs
  • Over 18 years old
  • Patients requiring painless gastroenteroscopy for various reasons

Exclusion Criteria:

  • Unable or unwilling to sign a consent form, or unable to follow research procedures
  • have contraindications to painless gastroenteroscopy
  • Vital signs are unstable
  • The lesions have been identified by gastroenteroscopy in other hospitals, which is to further confirm the patients who come to our hospital for endoscopic examination
  • Endoscopic treatment, such as polypectomy, pylorus narrow dilatation and so on

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
A: Model A
Mode A was silent mode, back-to-back with endoscopic physicians to simultaneously display endoscopic images and record video, but did not interfere with the operation of endoscopic physicians.After the operation, the AI model automatically generates an endoscopy report, which is compared with the official report given by the endoscopy doctor in the endoscopy system. If the difference is large, video verification shall be played back immediately or endoscopic examination shall be performed again before the patient wakes up
Behavioral: Careful examination during endoscopic procedures to identify lesions
When the AI model alarms, check carefully to confirm the lesion
B: Model B
Mode B is a delayed reminder mode. If the lesion is found during the operation, it is required to be moved to the middle of the visual field within 5 seconds. If the lesion has been detected by the AI model (the lesion has been circled in the picture), but the doctor does not move the lesion to the middle of the visual field within 5 seconds, the AI system will give an alarm prompt
Behavioral: Careful examination during endoscopic procedures to identify lesions
When the AI model alarms, check carefully to confirm the lesion
C: Model C
Mode C is a real-time reminder mode, which is an alarm prompt when the focus is captured in the visual field.
Behavioral: Careful examination during endoscopic procedures to identify lesions
When the AI model alarms, check carefully to confirm the lesion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of detection rate of digestive tract lesions assisted by artificial intelligence gastroenteroscopy
Time Frame: 2 years
Endoscopic examination has a high dependence on the clinical experience and status of endoscopists, and the quality of endoscopic examination of endoscopists can be reduced by high-load work, and problems such as incomplete examination site coverage, incomplete detection of lesions, and incomplete image collection are easy to occur. Artificial intelligence does not have this weakness. It does not reduce its ability to work over a long period of time, and its assistance is expected to improve the detection rate of lesions
2 years
The accuracy of AI-assisted diagnostic model evaluating the intestinal readiness score
Time Frame: 2 years
The quality of intestinal preparation determines the quality of colonoscopy, which is evaluated by endoscopists through the Boston score. The ai-assisted diagnostic model can also be automatically graded.The Boston bowel score is used to determine whether the bowel is adequately prepared. The Boston bowel score is divided into 4 grades (0~3 points) from worst to cleanest. The higher the score is, the better the bowel is prepared and more conducive to colonoscopy.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Cai J Ting, Dr, Second affiliated hospital of school of medicine, zhejiang university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 研2019-262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will not share to others

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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