- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362657
Computer Aided Diagnosis in Upper GI Endoscopy (AIOGD)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Man Yee YUNG, RN
- Phone Number: +85235052956
- Email: myyung@surgery.cuhk.edu.hk
Study Contact Backup
- Name: Shannon Chan, FRCSEd
- Phone Number: +85235053952
- Email: shannonchan@surgery.cuhk.edu.hk
Study Locations
-
-
-
Hong Kong, Hong Kong, 00000
- Combined Endoscopy Center, Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer aided diagnosis
Using CAD to assist in completeness of the examination during OGD
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anatomical coverage during OGD by CAD
Time Frame: 24 hours
|
Rate of complete examination of the Upper GI tract during OGD guided by CAD
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure time
Time Frame: 24 hours
|
Time to complete the OGD
|
24 hours
|
Endoscopists satisfactory score
Time Frame: 24 hours
|
Assessment of satisfaction of endoscopists in application of CAD basing on VAS score 0 to 10
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Chiu, MD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC 2019.274.T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Upper Gastrointestinal Disorder
-
Cheju Halla General HospitalCompletedTolerance | Disorder of Upper Gastrointestinal Tract | C.Medical Procedure; Digestive SystemKorea, Republic of
-
AstraZenecaCompletedNSAIDs | Upper GI SymptomsSweden, United States, Czech Republic, Italy, South Africa, United Kingdom, Poland, Norway, Canada, Slovakia, Australia
-
AstraZenecaCompletedNSAIDs | Upper GI SymptomsSweden, United States, Czech Republic, Italy, South Africa, United Kingdom, Poland, Norway, Canada, Slovakia, Australia
-
Carol Davila University of Medicine and PharmacyNot yet recruitingUpper Gastrointestinal Endoscopy
-
Taipei Veterans General Hospital, TaiwanUnknownUpper Gastrointestinal EndoscopyTaiwan
-
Ain Shams UniversityCompletedUpper Gastrointestinal EndoscopyEgypt
-
University Hospital, CaenCompletedUpper Gastrointestinal EndoscopyFrance
-
Universidade de Passo FundoFederal University of Rio Grande do SulCompleted
-
AnX Robotica Corp.CompletedUpper Gastrointestinal SymptomsUnited States
-
Mahmoud Mohammed Osman AliAssiut UniversityCompletedUpper Gastrointestinal EndoscopyEgypt
Clinical Trials on Computer Aided Diagnosis
-
Tri-Service General HospitalUnknown
-
King's College Hospital NHS TrustCompletedColorectal Cancer | Colonic PolypUnited Kingdom
-
Chinese University of Hong KongRecruitingColonic PolypHong Kong
-
Changi General HospitalNational University Hospital, Singapore; Singapore General Hospital; Tan Tock...CompletedColonic Polyp | Colonic Neoplasms | Colonic DysplasiaSingapore
-
Doctors with Africa - CUAMMUniversity of Bari; Armauer Hansen Research Institute, EthiopiaNot yet recruitingTuberculosis | Diagnosis | geneXpertEthiopia
-
University College, LondonNot yet recruitingPolyps | Colon Polyp | Adenoma Colon | Colorectal Polyp | Polyps of ColonUnited Kingdom
-
Maastricht University Medical CenterCatharina Ziekenhuis Eindhoven; Eindhoven University of TechnologyCompletedColorectal Cancer | Colorectal PolypNetherlands
-
Theodor Bilharz Research InstituteRecruitingColorectal CancerEgypt
-
Singapore General HospitalCompleted
-
University School of Physical Education in WroclawKessler Foundation; Wrocław University of Science and Technology; Nencki Institute... and other collaboratorsUnknown