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

Wuhan University

Status: Unknown

Conditions: Artificial Intelligence; Colonic Diseases

Treatments: Diagnostic Test: Endoscopists refer to AI for diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT04216901

EA-19-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. male or female aged 18 or above;
2. colonoscopy and related examinations should be performed to further clarify the characteristics of digestive tract diseases;
3. be able to read, understand and sign the informed consent;
4. 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;
5. patients with > 1cm lesion detected by colonoscopy, requiring magnification staining or surgical resection.

Exclusion criteria

1. have participated in other clinical trials, signed the informed consent and have been in the follow-up period of other clinical trials;
2. drug or alcohol abuse or psychological disorder in the last 5 years;
3. pregnant or nursing women;
4. subjects with previous history of intestinal surgery;
5. the researcher considers that the subject is not suitable for colonoscopy and related examination;
6. high-risk diseases or other special conditions that the investigator considers inappropriate for the subject to participate in the clinical trial.