Effect of AI Monitoring Blind Spots of EGD on the Inspection Time and Lesion Dection Rate

Upper Gastrointestinal Symptoms Clinical Trial

Official title:

Effect of Artificial Intelligence Monitoring Blind Spots of EGD on the Inspection Time and Dection Rate of Neoplastic Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05832411
• Other study ID #: EA-23-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2023
• Source: Renmin Hospital of Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinic trial is to learn about the effect of AI monitoring blind spots on the inspection time to EGD. Patients are randomly assigned to undergo an EGD with or without the assistance of AI. In the AI group, except for the original videos, there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring. Researchers will compare intervention group to see if it have a shorter inspection time compared with the control group.

Description:

The goal of this clinic trial is to evaluate the effect of real-time artificial intelligence for monitoring blind spots on the inspection time of EGD. Patients are randomly assigned to undergo an EGD with or without the assistance of AI. In the AI group, except for the original videos, there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring. Researchers will compare intervention group to see if it have a shorter inspection time in the case of non-inferior detection rate of gastric neoplastic lesions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1672
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. patients aged 18 years or older

2. patients able to give informed consent

3. American Society of Anesthesiology risk class 1,2 or 3

Exclusion Criteria:

1. patients with absolute contraindications to EGD examination

2. patients with a history of previous gastrectomy

3. patients with a serious underlying disease

4. pregnant patients

5. researchers believe that the patient is not suitable to participate in the trial

Related Conditions & MeSH terms

• Scotoma
• Upper Gastrointestinal Symptoms

Intervention

Device:
• Endoangle
there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

References & Publications (3)

Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available. — View Citation

Wu L, Xu M, Jiang X, He X, Zhang H, Ai Y, Tong Q, Lv P, Lu B, Guo M, Huang M, Ye L, Shen L, Yu H. Real-time artificial intelligence for detecting focal lesions and diagnosing neoplasms of the stomach by white-light endoscopy (with videos). Gastrointest Endosc. 2022 Feb;95(2):269-280.e6. doi: 10.1016/j.gie.2021.09.017. Epub 2021 Sep 20. — View Citation

Wu L, Zhang J, Zhou W, An P, Shen L, Liu J, Jiang X, Huang X, Mu G, Wan X, Lv X, Gao J, Cui N, Hu S, Chen Y, Hu X, Li J, Chen D, Gong D, He X, Ding Q, Zhu X, Li S, Wei X, Li X, Wang X, Zhou J, Zhang M, Yu HG. Randomised controlled trial of WISENSE, a real-time quality improving system for monitoring blind spots during esophagogastroduodenoscopy. Gut. 2019 Dec;68(12):2161-2169. doi: 10.1136/gutjnl-2018-317366. Epub 2019 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dection rate of neoplastic lesions	Proportion of patients with neoplastic lesions among all patients undergoing esophagogastroduodenoscopy.	Through study completion, an average of 1 year
Secondary	Inspection time	It is the time from intubation to extubation of the patient without biopsy.	20min