The Use of AI to Improve Quality of OGD

Anemia Clinical Trial

Official title:

The Use of Artificial Intelligence Real-time Feedback to Improve Compliance to a Standardised Protocol and Procedural Quality During Oesophagogastroduodenoscopy (OGD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04883567
• Other study ID #: 2021.061
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Acid Reflux
• Anemia
• Dyspepsia
• Dysphagia

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