A Single Center Study on the Effectiveness and Safety of Polyp Classification With Artificial Intelligence

  • STATUS
    Recruiting
  • participants needed
    70
  • sponsor
    Renmin Hospital of Wuhan University
Updated on 19 February 2024

Summary

This is an artificial intelligence-based optical endoscopic polyp diagnosis system that can assist endoscopic doctors in diagnosing polyps and improve the quality of training in clinical Settings.

Description

Large sessile and laterally spreading colorectal lesions(LSLs) are increasingly encountered during colonoscopy. LSLs have an increased risk of harbouring invasive cancer and can be challenging to excise endoscopically. Wide-field endoscopic mucosal resection (WF-EMR) is widely used in treating LSLs. In the East, meanwhile endoscopic submucosal dissection (ESD) is the dominant technique due to its ability to achieve en bloc resection in over 80% of cases. Many papers have demonstrated that selective-esd has the highest economic benefit. The key is to find a reliable way to select.

Details
Condition Colonic Diseases, Intestinal Diseases, Artificial Intelligence
Age 18-100 years
Treatment Endoscopists refer to AI for diagnosis
Clinical Study IdentifierNCT04216901
SponsorRenmin Hospital of Wuhan University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

male or female aged 18 or above
colonoscopy and related examinations should be performed to further clarify the characteristics of digestive tract diseases
be able to read, understand and sign the informed consent
the researcher believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures
patients with > 1cm lesion detected by colonoscopy, requiring magnification staining or surgical resection

Exclusion Criteria

have participated in other clinical trials, signed the informed consent and have been in the follow-up period of other clinical trials
drug or alcohol abuse or psychological disorder in the last 5 years
pregnant or nursing women
subjects with previous history of intestinal surgery
the researcher considers that the subject is not suitable for colonoscopy and related examination
high-risk diseases or other special conditions that the investigator considers inappropriate for the subject to participate in the clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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