Colon PolypNCT05990218
Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Different Operator Experience
A study testing Artificial intellegence. CADe syste, in people with Colon Polyp, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Polyp
- What is being tested?
- Artificial intellegence. CADe syste,
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteThailand
- Study dates
- 13 Feb 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants age 40-80 years
Who cannot join
- History of colonic surgery (except appendectomy)
- Lower gastrointestinal bleeding
- unstable vital sign during endoscopy of pregnancy
- history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Rajavithi Hospital
Bangkok, Bangkok
Tanyaporn Chantarojanasiri, MD, 0898104033, chtunya@gmail.com
Tanyaporn Chantarojanasiri, MD
About this study
Official title: Efficacy of Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Operators with Different Endoscopic Experience: a Randomized Control Trial
Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.
- Conditions
- Colon Polyp
- Being tested
- Artificial intellegence. CADe syste,, control
- Keywords
- colon polyp, artificial intellegence, colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intellegence. CADe syste,Device
The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.
controlDevice
The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| control, experienced | Active comparator | Patients received colonoscopy with double insertion of right sided colon under white light by experienced endoscopist Receives: Device: control |
| control, beginner | Active comparator | Patients received colonoscopy with double insertion of right sided colon under white light by beginner endoscopist Receives: Device: control |
| AI, experience | Experimental | Patients received colonoscopy with double insertion of right sided colon under AI by experienced endoscopist Receives: Device: Artificial intellegence. CADe syste, |
| AI, beginner | Experimental | Patients received colonoscopy with double insertion of right sided colon under AI by beginner endoscopist Receives: Device: Artificial intellegence. CADe syste, |
What is being measured
The primary outcome is the main question the study is designed to answer.
polyp detection rate
the number of polyp detected during endoscopy
Measured: during endoscopy
Secondary outcomes (1)
type of polyp
the type of polyp detected during endoscopy
Measured: during endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start13 Feb 2023
- Primary completion12 Feb 2026 (estimated)
- Study completion28 Feb 2026 (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 Colon PolypStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to 4 arms: control with experienced operator, control with beginner operator, AI with experienced operator, AI with beginner operator
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990218
- Sponsor's protocol ID
- 031/2566
- Status last verified
- Dec 2024
- First submitted
- 6 Aug 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamba S, Tamai N, Saitoh I, Matsui H, Horiuchi H, Kobayashi M, Sakamoto T, Ego M, Fukuda A, Tonouchi A, Shimahara Y, Nishikawa M, Nishino H, Saito Y, Sumiyama K. Reducing adenoma miss rate of colonoscopy assisted by artificial intelligence: a multicenter randomized controlled trial. J Gastroenterol. 2021 Aug;56(8):746-757. doi: 10.1007/s00535-021-01808-w. Epub 2021 Jul 3.
PubMed 34218329
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Operators with Different Endoscopic Experience: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05990218
- Acronym / sponsor ID
- 031/2566
- Conditions
- Colon Polyp
- Keywords
- colon polyp, artificial intellegence, colonoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 12 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 14 Aug 2023 (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.
Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Patients randomized to 4 arms: control with experienced operator, control with beginner operator, AI with experienced operator, AI with beginner operator
| Arm | Type | Receives |
|---|---|---|
| control, experienced | Active comparator | Device: controlPatients received colonoscopy with double insertion of right sided colon under white light by experienced endoscopist |
| control, beginner | Active comparator | Device: controlPatients received colonoscopy with double insertion of right sided colon under white light by beginner endoscopist |
| AI, experience | Experimental | Device: Artificial intellegence. CADe syste,Patients received colonoscopy with double insertion of right sided colon under AI by experienced endoscopist |
| AI, beginner | Experimental | Device: Artificial intellegence. CADe syste,Patients received colonoscopy with double insertion of right sided colon under AI by beginner endoscopist |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants age 40-80 years
Key exclusion criteria (4 listed)
- History of colonic surgery (except appendectomy)
- Lower gastrointestinal bleeding
- unstable vital sign during endoscopy of pregnancy
- history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure
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 |
|---|---|---|
| Artificial intellegence. CADe syste,The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal. | Device | AI, beginner, AI, experience |
| controlThe patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal. | Device | control, beginner, control, experienced |
Primary outcome
polyp detection rate
Time frame: during endoscopy
the number of polyp detected during endoscopy
1 secondary outcome
type of polyp
Time frame: during endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 34218329Kamba S, Tamai N, Saitoh I, Matsui H, Horiuchi H, Kobayashi M, Sakamoto T, Ego M, Fukuda A, Tonouchi A, Shimahara Y, Nishikawa M, Nishino H, Saito Y, Sumiyama K. Reducing adenoma miss rate of colonoscopy assisted by artificial intelligence: a multicenter randomized controlled trial. J Gastroenterol. 2021 Aug;56(8):746-757. doi: 10.1007/s00535-021-01808-w. Epub 2021 Jul 3.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intellegence. CADe syste, in people with Colon Polyp, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polyp detection rate (time frame: during endoscopy). 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 NCT05990218, 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 Dec 2024.