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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04883567
Other study ID # 2021.061
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date June 30, 2022

Study information

Verified date May 2021
Source Chinese University of Hong Kong
Contact Shannon Chan
Phone 35052627
Email shannonchan@surgery.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Early and accurate recognition of gastrointestinal lesions has implications for public health. The quality of oesophagogastroduodenoscopy (OGD) has great impact on the detection of oesophageal and gastric malignancies. An AI system, Cerebro, has been developed as a real-time recognition of a pre-defined 28 locations. This system would alert the endoscopist if the sites were not inspected with adequate time. The aim of the study is to investigate the use of AI in endoscopists-in-training during OGD to provide a real-time feedback for ensuring compliance to a standardized protocol for examination. The hypothesis is that the use of AI system Cerebro will significantly improve the compliance to the protocol and thereby reduce the blind spot rates of OGD, ensure adequate inspection time and ensure adequate photodocumentation.


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date June 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. All patients aged >= 18 years old 2. Undergoing diagnostic OGD for evaluation of their symptoms in the Prince of Wales Hospital will be included in the study. Exclusion Criteria: 1. Patients in which a full endoscopic examination is not required including patients with a specific diagnostic purpose without the need for a full evaluation, follow-up endoscopy within 8 weeks for a previously diagnosed disease or condition, 2. Patients' condition requiring therapeutic endoscopy, 3. Early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety, 4. Patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or Whipple's operation, 5. Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel) 6. Pregnant females 7. Patients who refuse to participate in the study 8. Patients who are unfit for consent.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
The use of artificial intelligence system Cerebro
The artificial intelligence system Cerebro would be used during OGD

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of sites inspected during OGD There is a standardised 28 sites the trainee endoscopist need to inspect During the procedure
Secondary Overall inspection time The overall inspection time during the OGD would be recorded in terms of seconds During the procedure
Secondary The individual sites inspection time The individual inspection time of the 28 sites during OGD would be recorded in terms of seconds During the procedure
Secondary The number of positive pathologies found on OGD The number of positive pathologies found on OGD would be recorded during the procedure
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