Healthy IndividualNCT05452473
CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy
A study testing CDSS-assisted upper GI endoscopy in people with Healthy Individual, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Individual
- What is being tested?
- CDSS-assisted upper GI endoscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2022to 6 Dec 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who visited for routine screening upper gastrointestinal endoscopy
Who cannot join
- Participants who refuse to participate in this study
- Participants who showed paradoxical reaction prohibiting routine examination
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chuncheon Sacred Heart hospital
Chuncheon, Gangwon-do, 24253
Chang Seok Bang, MD, PHD, +82332405000, cloudslove@naver.com
Cho Won Kim, MS, +82332405000, kimcw0731@hallym.or.kr
About this study
Official title: Clinical Benefit in the CDSS-assisted Screening Upper Gastrointestinal Endoscopy vs. Routine Screening Endoscopy
This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups.
Read the detailed description
Artificial intelligence has been adopted in the field of gastrointestinal endoscopy. Investigators previously established deep-learning models to predict the histology and invasion depth of gastric lesions using endoscopic stillcut images. However, clinical benefit of this model has not been evaluated. This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients who visited Chuncheon Sacred Heart hospital will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups. Expert endoscopists will conduct this randomized study.
- Conditions
- Healthy Individual
- Being tested
- CDSS-assisted upper GI endoscopy, no intervention
- Keywords
- Convolutional neural network, Deep learning, Endoscopy, Gastric neoplasms
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSS-assisted upper GI endoscopyOther
Expert endoscopists perform screening upper gastrointestinal endoscopy while looking at the monitor (CDSS system: automatic detection or lesion classification function) and listening to the sound of the monitor next to the original endoscopy monitor system.
no interventionOther
Expert endoscopists perform routine screening upper gastrointestinal endoscopy without CDSS's help.
| Study group | Role | What they receive |
|---|---|---|
| CDSS-assisted screening endoscopy | Experimental | Participants will be tested for CDSS-assisted screening upper gastrointestinal endoscopy Receives: Other: CDSS-assisted upper GI endoscopy |
| Conventional routine screening endoscopy | Placebo comparator | Participants will be tested for Conventional routine screening upper gastrointestinal endoscopy Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric lesion detection rate
Gastric lesions (low or high grade dysplasia, early gastric cancer, or advanced gastric cancer) detection rate
Measured: Baseline (gold standard; ground truth is expert endoscopists' lesion detection)
Secondary outcomes (1)
Lesion classification accuracy
Whether CDSS correctly diagnosed detected lesions or not
Measured: Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start6 Jul 2022
- Primary completion6 Aug 2022 (estimated)
- Study completion6 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Seok Bang, Chuncheon Sacred Heart Hospital
- Investigators
- Chang Seok Bang, MD, PhD, Principal investigator, Hallym University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452473
- Sponsor's protocol ID
- AI RCT1
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gong EJ, Bang CS, Lee JJ, Baik GH, Lim H, Jeong JH, Choi SW, Cho J, Kim DY, Lee KB, Shin SI, Sigmund D, Moon BI, Park SC, Lee SH, Bang KB, Son DS. Deep learning-based clinical decision support system for gastric neoplasms in real-time endoscopy: development and validation study. Endoscopy. 2023 Aug;55(8):701-708. doi: 10.1055/a-2031-0691. Epub 2023 Feb 8.
PubMed 36754065
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefit in the CDSS-assisted Screening Upper Gastrointestinal Endoscopy vs. Routine Screening Endoscopy
- ClinicalTrials.gov ID
- NCT05452473
- Acronym / sponsor ID
- AI RCT1
- Conditions
- Healthy Individual
- Keywords
- Convolutional neural network, Deep learning, Endoscopy, Gastric neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 6 Aug 2022 (estimated)
- Study completion
- 6 Dec 2022 (estimated)
- First posted
- 11 Jul 2022 (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 find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups.
Detailed description
Artificial intelligence has been adopted in the field of gastrointestinal endoscopy. Investigators previously established deep-learning models to predict the histology and invasion depth of gastric lesions using endoscopic stillcut images. However, clinical benefit of this model has not been evaluated. This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients who visited Chuncheon Sacred Heart hospital will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups. Expert endoscopists will conduct this randomized study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDSS-assisted screening endoscopy | Experimental | Other: CDSS-assisted upper GI endoscopyParticipants will be tested for CDSS-assisted screening upper gastrointestinal endoscopy |
| Conventional routine screening endoscopy | Placebo comparator | Other: no interventionParticipants will be tested for Conventional routine screening upper gastrointestinal endoscopy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who visited for routine screening upper gastrointestinal endoscopy
Key exclusion criteria (2 listed)
- Participants who refuse to participate in this study
- Participants who showed paradoxical reaction prohibiting routine examination
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 |
|---|---|---|
| CDSS-assisted upper GI endoscopyExpert endoscopists perform screening upper gastrointestinal endoscopy while looking at the monitor (CDSS system: automatic detection or lesion classification function) and listening to the sound of the monitor next to the original endoscopy monitor system. | Other | CDSS-assisted screening endoscopy |
| no interventionExpert endoscopists perform routine screening upper gastrointestinal endoscopy without CDSS's help. | Other | Conventional routine screening endoscopy |
Primary outcome
Gastric lesion detection rate
Time frame: Baseline (gold standard; ground truth is expert endoscopists' lesion detection)
Gastric lesions (low or high grade dysplasia, early gastric cancer, or advanced gastric cancer) detection rate
1 secondary outcome
Lesion classification accuracy
Time frame: Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Derived from this study: PubMed 36754065Gong EJ, Bang CS, Lee JJ, Baik GH, Lim H, Jeong JH, Choi SW, Cho J, Kim DY, Lee KB, Shin SI, Sigmund D, Moon BI, Park SC, Lee SH, Bang KB, Son DS. Deep learning-based clinical decision support system for gastric neoplasms in real-time endoscopy: development and validation study. Endoscopy. 2023 Aug;55(8):701-708. doi: 10.1055/a-2031-0691. Epub 2023 Feb 8.
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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.
Chang Seok Bang, MD, PhD principal investigator
Hallym University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS-assisted upper GI endoscopy in people with Healthy Individual, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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 1 inclusion and 2 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 13 Jul 2022. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 Chang Seok Bang, MD., PhD. (+82332405000, csbang@hallym.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric lesion detection rate (time frame: Baseline (gold standard; ground truth is expert endoscopists' lesion detection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452473, which also lists 1 linked publication.
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 13 Jul 2022.