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

NCT ID: NCT04216901

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-24
• Study Completion Date: 2021-06-30

Brief 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.

Detailed 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.

Conditions

Colonic Diseases; Artificial Intelligence

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Endoscopists refer to AI for diagnosis

The AI will provide a pathological prediction of the lesion during colonoscopy.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Honggang, MD

Role: PRINCIPAL_INVESTIGATOR

Wuhan University Renmin Hospital

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Honggang, MD

Role: CONTACT

yuhonggang1968@163.com

+86 13871281899

Facility Contacts

Honggang Yu, MD

Role: primary

yuhonggang1968@163.com

+8613871281899

Other Identifiers

EA-19-003

Identifier Type: -

Identifier Source: org_study_id