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

NCT04216901 | Unknown

• 1 other identifier: EA-19-003
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases; Artificial Intelligence

Keywords

Colonic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Accuracy of evaluating the feasibility of selective-ESD

  Calculate the accuracy of ai's judgment on whether ESD should be implemented.Accuracy is: the machine over a period of time to judge the results are consistent with the pathological lesion number of molecules, all lesions detected by a period of time for the denominator expressed as a percentage.The gold standard is the pathological results of diagnostic treatment. After the specimen was removed, the area suspected by endoscopists of early cancer was marked with Indian ink for pathological recovery.The specimens were then placed in formalin and fixed for 24 hours until the ink was a little dry.Even if the specimen is cut into 2mm-wide shapes, the suspected area can be identified by Indian ink staining under a microscope.The doctor suspected cancer patients were followed up for 60 days.

  2019.12.24-2020.12.31

• Accuracy of Vision location

  Calculate the accuracy of the machine in locating the field of vision.The accuracy was as follows: the visual field localization results of the machine on the ESD intraoperative lesion screen captures were the numerator consistent with the number of visual fields determined by multiple endoscopists, and the number of visual fields of all localization in the same operation was the denominator, and the result was expressed as a percentage.The consistent results of visual field positioning by multiple endoscopic physicians watching the operation video were the gold standard.Patients with suspected cancer were followed up for 60 days, and the most serious pathological diagnosis within 60 days was taken as the diagnosis of the patient's disease.Patients whose doctors deemed no risk were followed until the end of colonoscopy.

  2019.12.24-2020.12.31

Secondary Outcomes (3)

• Consistent of classification among different endoscopists

  2019.12.24-2020.12.31

• Consistent of classification between diagnostic system and endoscopists

  2019.12.24-2020.12.31

• Consistent of vision positioning between diagnostic system and endoscopists

  2019.12.24-2020.12.31

Interventions

Endoscopists refer to AI for diagnosis DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with larger than 10mm in size intestinal polyps.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colonoscopy Images and colonoscopy videos

MeSH Terms

Conditions

Colonic Diseases; Colonic Neoplasms

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Yu Honggang, MD

  Wuhan University Renmin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Honggang, MD

CONTACT

+86 13871281899; yuhonggang1968@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 3, 2020
• Study Start: December 24, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)