Artificial IntelligenceNCT05293457
AI-assisted Gastroscopic Varicose Vein Diagnosis
An observational study of Artificial Intelligence, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
Validation of the accuracy of AI in assisting gastroscopic varices diagnosis through a prospective multicenter study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence
- How many people
- 793 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 25 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with cirrhosis who visited each center of the study from February 2022 to December 2022.
Who may be able to join
- Male or female aged 18 years or above;
- Gastroscopy and related examinations are required to further clarify the characteristics of digestive tract diseases;
- Patients with liver cirrhosis who have signs or symptoms of portal hypertension and have clinical indications for endoscopic screening for varicose veins.
- Able to read, understand and sign the informed consent;
- The researcher believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.
Who cannot join
- 1) Pregnant or breastfeeding women; 2) Patients with a history of esophagogastric surgery; 3) Patients who have received interventional or endoscopic treatment in the past; 4) The patient has high-risk diseases or other special conditions that are not suitable for participating in clinical trials; 5) The patient is clearly diagnosed with esophageal or gastric diverticulum, polyps, cancer and other diseases that may affect the observation of varicose veins; 6) The patient's endoscopic video cannot reach a consensus diagnosis and treatment opinion after being watched by three experts.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Study of AI-assisted Gastroscopic Varices Diagnosis
Validation of the accuracy of AI in assisting gastroscopic varices diagnosis through a prospective multicenter study
Read the detailed description
This study is a multi-center prospective study. Patients who meet the inclusion and exclusion criteria of the study will collect their basic information during outpatient and hospitalization. The designated doctor will introduce the significance of this study to the patients and sign the informed consent. After the endoscopy of the patient, the video of the operation under the endoscope was collected and saved, and the AI was imported to obtain its conclusions on the above characteristics, as well as stratification and treatment recommendations. Follow-up requirements for third-party physicians who meet the inclusion criteria, record their various diagnosis and treatment recommendations after watching the video (mainly in the form of a selection questionnaire to avoid subjective bias), and the content of the questionnaire includes the veins observed in the endoscopic operation video. Varicose related features (with or without red sign, bleeding sign, varicose vein shape, diameter, color, mucosal sign), and corresponding risk stratification and treatment recommendations are required. For videos with inconsistent conclusions between AI and physicians, physicians will be asked to watch these videos with AI prompts again to give their opinions, and there will be a two-week buffer period between the first time and the second viewing. The reference standard for diagnosis will be obtained by three endoscopists watching videos without AI prompts, and the conclusions drawn by the three experts will be used as the reference standard. When the three experts have inconsistent conclusions, the three experts will discuss A consensus shall prevail. If no consensus can be reached in the end, the video will be discarded.
Primary and secondary endpoints were obtained by comparing the accuracy of diagnosis made by physicians and AI. All data were analyzed by SPSS statistical software.
- Conditions
- Artificial Intelligence
- Keywords
- artificial intelligence, Varicose veins, Cirrhosis
- Medical subject headings
- Varicose Veins, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of artificial intelligence
Accuracy of AI in the description and treatment recommendations of esophagogastric varices diagnosis and endoscopic findings (form, color, red sign, hemorrhagic sign, and mucosal findings).
Measured: 2022/12/25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start25 Apr 2022 (estimated)
- Primary completion25 Oct 2022 (estimated)
- Study completion25 Dec 2022 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 793 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293457
- Sponsor's protocol ID
- WDRY2022-K014
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of AI-assisted Gastroscopic Varices Diagnosis
- ClinicalTrials.gov ID
- NCT05293457
- Acronym / sponsor ID
- WDRY2022-K014
- Conditions
- Artificial Intelligence
- Keywords
- artificial intelligence, Varicose veins, Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 793 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 25 Oct 2022 (estimated)
- Study completion
- 25 Dec 2022 (estimated)
- First posted
- 24 Mar 2022 (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.
Validation of the accuracy of AI in assisting gastroscopic varices diagnosis through a prospective multicenter study
Detailed description
This study is a multi-center prospective study. Patients who meet the inclusion and exclusion criteria of the study will collect their basic information during outpatient and hospitalization. The designated doctor will introduce the significance of this study to the patients and sign the informed consent. After the endoscopy of the patient, the video of the operation under the endoscope was collected and saved, and the AI was imported to obtain its conclusions on the above characteristics, as well as stratification and treatment recommendations. Follow-up requirements for third-party physicians who meet the inclusion criteria, record their various diagnosis and treatment recommendations after watching the video (mainly in the form of a selection questionnaire to avoid subjective bias), and the content of the questionnaire includes the veins observed in the endoscopic operation video. Varicose related features (with or without red sign, bleeding sign, varicose vein shape, diameter, color, mucosal sign), and corresponding risk stratification and treatment recommendations are required. For videos with inconsistent conclusions between AI and physicians, physicians will be asked to watch these videos with AI prompts again to give their opinions, and there will be a two-week buffer period between the first time and the second viewing. The reference standard for diagnosis will be obtained by three endoscopists watching videos without AI prompts, and the conclusions drawn by the three experts will be used as the reference standard. When the three experts have inconsistent conclusions, the three experts will discuss A consensus shall prevail. If no consensus can be reached in the end, the video will be discarded.
Primary and secondary endpoints were obtained by comparing the accuracy of diagnosis made by physicians and AI. All data were analyzed by SPSS statistical software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis who visited each center of the study from February 2022 to December 2022.
Key inclusion criteria (5 listed)
- Male or female aged 18 years or above;
- Gastroscopy and related examinations are required to further clarify the characteristics of digestive tract diseases;
- Patients with liver cirrhosis who have signs or symptoms of portal hypertension and have clinical indications for endoscopic screening for varicose veins.
- Able to read, understand and sign the informed consent;
- The researcher believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.
Key exclusion criteria (2 listed)
- 1) Pregnant or breastfeeding women; 2) Patients with a history of esophagogastric surgery; 3) Patients who have received interventional or endoscopic treatment in the past; 4) The patient has high-risk diseases or other special conditions that are not suitable for participating in clinical trials; 5) The patient is clearly diagnosed with esophageal or gastric diverticulum, polyps, cancer and other diseases that may affect the observation of varicose veins; 6) The patient's endoscopic video cannot reach a consensus diagnosis and treatment opinion after being watched by three experts.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of artificial intelligence
Time frame: 2022/12/25
Accuracy of AI in the description and treatment recommendations of esophagogastric varices diagnosis and endoscopic findings (form, color, red sign, hemorrhagic sign, and mucosal findings).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artificial Intelligence, 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 2 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 24 Mar 2022. 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?
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?
The accuracy of artificial intelligence (time frame: 2022/12/25). 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 24 Mar 2022.