Clinical trial NCT04216901: A Single Center Study on the Effectiveness and Safety of Polyp Classification With Artificial Intelligence
Official title: A Single Center Study on the Effectiveness and Safety of Polyp Detection and Polyp Classification With Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Diseases
Artificial Intelligence
Keywords: Colonic Neoplasms
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with larger than 10mm in size intestinal polyps.

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.

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.

Primary outcomes:
measure: Accuracy of evaluating the feasibility of selective-ESD
timeFrame: 2019.12.24-2020.12.31
measure: Accuracy of Vision location
timeFrame: 2019.12.24-2020.12.31
Secondary outcomes:
measure: Consistent of classification among different endoscopists
timeFrame: 2019.12.24-2020.12.31
measure: Consistent of classification between diagnostic system and endoscopists
timeFrame: 2019.12.24-2020.12.31
measure: Consistent of vision positioning between diagnostic system and endoscopists
timeFrame: 2019.12.24-2020.12.31
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University Renmin Hospital
name: Yu Honggang, MD
role: PRINCIPAL_INVESTIGATOR
References: