Upper Gastrointestinal DisorderAIOGDNCT04362657
Computer Aided Diagnosis in Upper GI Endoscopy
A study testing Computer Aided Diagnosis in people with Upper Gastrointestinal Disorder and OGD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Disorder, OGD
- What is being tested?
- Computer Aided Diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Apr 2020to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing diagnostic OGD for evaluation of their symptoms
- Age >= 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, 00000
About this study
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.
Read the 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.
- Conditions
- Upper Gastrointestinal Disorder, OGD
- Being tested
- Computer Aided Diagnosis
- Keywords
- Computer aided diagnosis, OGD
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Aided DiagnosisDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Computer aided diagnosis | Experimental | Using CAD to assist in completeness of the examination during OGD Receives: Diagnostic Test: Computer Aided Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical coverage during OGD by CAD
Rate of complete examination of the Upper GI tract during OGD guided by CAD
Measured: 24 hours
Secondary outcomes (2)
Procedure time
Time to complete the OGD
Measured: 24 hours
Endoscopists satisfactory score
Assessment of satisfaction of endoscopists in application of CAD basing on VAS score 0 to 10
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start20 Apr 2020
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Wai Yan CHIU, Chinese University of Hong Kong
- Investigators
- Philip Chiu, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362657
- Sponsor's protocol ID
- CREC 2019.274.T
- Acronym
- AIOGD
- Status last verified
- Nov 2023
- First submitted
- 22 Apr 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Aided Diagnosis in Upper GI Endoscopy
- ClinicalTrials.gov ID
- NCT04362657
- Acronym / sponsor ID
- AIOGD / CREC 2019.274.T
- Conditions
- Upper Gastrointestinal Disorder, OGD
- Keywords
- Computer aided diagnosis, OGD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer aided diagnosis | Experimental | Diagnostic Test: Computer Aided DiagnosisUsing CAD to assist in completeness of the examination during OGD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing diagnostic OGD for evaluation of their symptoms
- Age >= 18
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Aided DiagnosisComputer 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. | Diagnostic test | Computer aided diagnosis |
Primary outcome
Anatomical coverage during OGD by CAD
Time frame: 24 hours
Rate of complete examination of the Upper GI tract during OGD guided by CAD
2 secondary outcomes
Procedure time
Time frame: 24 hours
Endoscopists satisfactory score
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Chiu, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Aided Diagnosis in people with Upper Gastrointestinal Disorder and OGD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical coverage during OGD by CAD (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.