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Computer Aided Diagnosis in Upper GI Endoscopy (AIOGD)

Primary Purpose

Upper Gastrointestinal Disorder, OGD

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Computer Aided Diagnosis
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Upper Gastrointestinal Disorder focused on measuring Computer aided diagnosis, OGD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients undergoing diagnostic OGD for evaluation of their symptoms
  2. Age >= 18

Exclusion Criteria:

  1. Patients refusing consent/not willing to participate in the study
  2. Patients where biopsies cannot or have not been taken
  3. Patients with history of gastrectomy
  4. Patient admitted for upper gastrointestinal bleeding
  5. Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel)
  6. Pregnant females

Sites / Locations

  • Combined Endoscopy Center, Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computer aided diagnosis

Arm Description

Using CAD to assist in completeness of the examination during OGD

Outcomes

Primary Outcome Measures

Anatomical coverage during OGD by CAD
Rate of complete examination of the Upper GI tract during OGD guided by CAD

Secondary Outcome Measures

Procedure time
Time to complete the OGD
Endoscopists satisfactory score
Assessment of satisfaction of endoscopists in application of CAD basing on VAS score 0 to 10

Full Information

First Posted
April 22, 2020
Last Updated
May 1, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04362657
Brief Title
Computer Aided Diagnosis in Upper GI Endoscopy
Acronym
AIOGD
Official Title
Computer Aided Diagnosis in Upper GI Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to investigate the clinical application of Artificial Intelligence Software for computer aided diagnosis (CAD), for real-time anatomical coverage, automatic Identification, classification and interpretation of abnormal lesions in upper GI endoscopy, and benchmarking their accuracy compared to endoscopists.
Detailed Description
5.1 Phase One This phase of the study is non-interventional. It involves two sections: training cohort and validation cohort. 5.1.1 Training Cohort Such artificial intelligence models typically need a lot of data to be fed in, so that it can predict the results with a good accuracy. Since it uses machine learning, the accuracy gets better with each data set that is fed in. For the training cohort, prospective collection of videos on diagnostic OGD would be done. Selected endoscopists would be primed on the examination protocol. Patients would be sedated and given oral N-acetylcysteine 30 mins before the procedure. Investigators will record basic epidemiological, analytical and clinical data from patient records. ICD-10 diagnostic codes or similar diagnostic recording measures and recorded lab data will be used to determine diagnosis. The Procedure will be done using Olympus 290 systems under conscious sedation after informed written consent. The procedure will be recorded and the video file will be saved for future use. Images of suspected lesions and certain anatomic landmarks will also be saved like Esophagus (upper, middle, lower), gastroesophageal junction, fundus, body and antrum of stomach, incisura and pylorus and first and second part of duodenum. These images will also be used in initial training of the CADT. Since all endoscopic procedures in the endoscopy centre of Prince of Wales Hospital have been recorded since December 2018, some OGD that has been performed will be screened for quality and would also be used in this training cohort. 150-200 patient videos would be marked at different anatomical sites by trained endoscopists. These videos would be anonymized. The training cohort would be repeated until the sensitivity and specificity are over 90%. 5.1.2 Validation Cohort After feeding these images to the software, a validation cohort would be performed. All consecutive patients undergoing diagnostic OGD meeting the inclusion and exclusion criteria in the Prince of Wales Hospital would be included in the study. The endoscopists would be blinded to the presence of the CADT and the standard protocol. The endoscopist would perform a diagnostic OGD as per usual practice. The procedure would be recorded and accessed by the CADT at the same time. The same video would be validated by a specialist endoscopist on the adequacy of the anatomical sites covered and the preparation of the stomach. This would be considered as the gold standard. The specialist endoscopist would be blinded to the result of the CADT. The CADT result would be compared against the specialist endoscopist. Sensitivity and specificity of the CADT results would be generated. If it is lower than 90%, further pictures/ videos have to be fed in for the training cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Disorder, OGD
Keywords
Computer aided diagnosis, OGD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer aided diagnosis
Arm Type
Experimental
Arm Description
Using CAD to assist in completeness of the examination during OGD
Intervention Type
Diagnostic Test
Intervention Name(s)
Computer Aided Diagnosis
Intervention Description
Computer Aided diagnosis is an environment-enhancing technology developed to aid humans to improve their accuracy, speed and confidence by providing live feedback during the procedure, on request, or after the procedure has been completed.
Primary Outcome Measure Information:
Title
Anatomical coverage during OGD by CAD
Description
Rate of complete examination of the Upper GI tract during OGD guided by CAD
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Procedure time
Description
Time to complete the OGD
Time Frame
24 hours
Title
Endoscopists satisfactory score
Description
Assessment of satisfaction of endoscopists in application of CAD basing on VAS score 0 to 10
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing diagnostic OGD for evaluation of their symptoms Age >= 18 Exclusion Criteria: Patients refusing consent/not willing to participate in the study Patients where biopsies cannot or have not been taken Patients with history of gastrectomy Patient admitted for upper gastrointestinal bleeding Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel) Pregnant females
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Chan, FRCSEd
Phone
+85235053952
Email
shannonchan@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Man Yee Yung, RN
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chiu, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Combined Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Chiu, MD
Phone
85226322627
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Man Yee Yung
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Computer Aided Diagnosis in Upper GI Endoscopy

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