DyspepsiaNCT04883567
The Use of AI to Improve Quality of OGD
An observational study of Dyspepsia and Anemia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia, Anemia, Acid Reflux
- What is being tested?
- The use of artificial intelligence system Cerebro
- How many people
- 210 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2021to 30 Jun 2022
- Phase
- Observational
- 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
Study population: The study includes all patients who require an OGD in the Prince of Wales Hospital. The inclusion and exclusion criteria were stated in the previous section.
Who may be able to join
- All patients aged >= 18 years old
- Undergoing diagnostic OGD for evaluation of their symptoms in the Prince of Wales Hospital will be included in the study.
Who cannot join
- 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,
- Patients' condition requiring therapeutic endoscopy,
- Early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety,
- Patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or Whipple's operation,
- Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel)
- Pregnant females
- Patients who refuse to participate in the study
- Patients who are unfit for consent.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong, 0000
Shannon Chan, 35052627, shannonchan@surgery.cuhk.edu.hk
About this study
Official title: The Use of Artificial Intelligence Real-time Feedback to Improve Compliance to a Standardised Protocol and Procedural Quality During Oesophagogastroduodenoscopy (OGD)
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.
- Conditions
- Dyspepsia, Anemia, Acid Reflux, Dysphagia
- Being tested
- The use of artificial intelligence system Cerebro
- Keywords
- oesophagogastroduodenoscopy (OGD), artificial intelligence, quality of OGD
- Medical subject headings
- Dyspepsia, Anemia, Gastroesophageal Reflux, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of artificial intelligence system CerebroDiagnostic test
The artificial intelligence system Cerebro would be used during OGD
| Study group | Role | What they receive |
|---|---|---|
| AI arm | AI would be used to assist the trainee endoscopist Receives: Diagnostic Test: The use of artificial intelligence system Cerebro | |
| Non-AI arm | Trainee endoscopist would perform OGD as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of sites inspected during OGD
There is a standardised 28 sites the trainee endoscopist need to inspect
Measured: During the procedure
Secondary outcomes (3)
Overall inspection time
The overall inspection time during the OGD would be recorded in terms of seconds
Measured: During the procedure
The individual sites inspection time
The individual inspection time of the 28 sites during OGD would be recorded in terms of seconds
Measured: During the procedure
The number of positive pathologies found on OGD
The number of positive pathologies found on OGD would be recorded
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883567
- Sponsor's protocol ID
- 2021.061
- Status last verified
- May 2021
- First submitted
- 27 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Artificial Intelligence Real-time Feedback to Improve Compliance to a Standardised Protocol and Procedural Quality During Oesophagogastroduodenoscopy (OGD)
- ClinicalTrials.gov ID
- NCT04883567
- Acronym / sponsor ID
- 2021.061
- Conditions
- Dyspepsia, Anemia, Acid Reflux, Dysphagia
- Keywords
- oesophagogastroduodenoscopy (OGD), artificial intelligence, quality of OGD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 12 May 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI arm | – | Diagnostic Test: The use of artificial intelligence system CerebroAI would be used to assist the trainee endoscopist |
| Non-AI arm | – | –Trainee endoscopist would perform OGD as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes all patients who require an OGD in the Prince of Wales Hospital. The inclusion and exclusion criteria were stated in the previous section.
Key inclusion criteria (2 listed)
- All patients aged >= 18 years old
- Undergoing diagnostic OGD for evaluation of their symptoms in the Prince of Wales Hospital will be included in the study.
Key exclusion criteria (8 listed)
- 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,
- Patients' condition requiring therapeutic endoscopy,
- Early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety,
- Patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or Whipple's operation,
- 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 |
|---|---|---|
| The use of artificial intelligence system CerebroThe artificial intelligence system Cerebro would be used during OGD | Diagnostic test | AI arm |
Primary outcome
The number of sites inspected during OGD
Time frame: During the procedure
There is a standardised 28 sites the trainee endoscopist need to inspect
3 secondary outcomes
Overall inspection time
Time frame: During the procedure
The individual sites inspection time
Time frame: During the procedure
The number of positive pathologies found on OGD
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspepsia and Anemia, 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 8 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: status not confirmed, as of the sponsor's last update on 12 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon Chan (35052627, shannonchan@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of sites inspected during OGD (time frame: During the procedure). 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 12 May 2021.