Colorectal NeoplasmsSinoAIADRNCT03840590
Adenoma Detection Rate Using AI System in China
A study testing CSK AI system and Standard Colonoscopy in people with Colorectal Neoplasms and Colonic Polyp, run by Changhai Hospital at 4 sites in China.
Trial summary
The primary aim of this study is to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence is used. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Colonic Polyp, Adenoma
- What is being tested?
- CSK AI system and Standard Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 743 participants
- Where
- 4 sitesChina
- Study dates
- 10 Jul 2019to 5 Dec 2019
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients referred for screening, surveillance, or diagnostic colonoscopy
- All patients must be able to give informed consent
Who cannot join
- Patients with any absolute contraindications to colonoscopy
- Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
- Patients with known colon cancer or polyposis syndromes
- Patients with known colonic strictures
- Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
- Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
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- Patients lacking capacity to give informed consent
- Pregnancy
- Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
- Patients who are attending for a therapeutic procedure or assessment of a known lesion
Trial locations and contacts
4 sites in 1 country.
China4 sites
Sixth affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300100
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
About this study
Official title: Adenoma Detection Rate Using Artificial Intelligence System in China
The primary aim of this study is
- to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence is used.
Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Read the detailed description
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".
A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there is a significant improvement in detection of adenomas when the system is used. This study will randomize patients coming for colonoscopy to have their procedure performed as usual or as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 4 centers, recruiting a total of 800 participants.
- Conditions
- Colorectal Neoplasms, Colonic Polyp, Adenoma
- Being tested
- CSK AI system, Standard Colonoscopy
- Keywords
- adenoma detection rate
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSK AI systemDevice
CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.
Standard ColonoscopyDevice
This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted Colonoscopy | Experimental | Participants in this arm undergo AI-assisted colonoscopy using CSK AI system. Receives: Device: CSK AI system |
| Standard Colonoscopy | Active comparator | Participants in this arm undergo standard colonoscopy. Receives: Device: Standard Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate, ADR
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
Measured: At the end of the procedure, up to 1 hour.
Secondary outcomes (1)
Polyp detection rate, PDR
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
Measured: At the end of the procedure, up to 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start10 Jul 2019
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.
- Masking
- None (open label)
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Shanghai Zhongshan Hospital, Tianjin People's Hospital, Tianjin Nankai Hospital
- Responsible party
- Principal investigator, En-Da Yu, Changhai Hospital
- Investigators
- En-Da YU, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840590
- Sponsor's protocol ID
- SINOCOLO2019B
- Acronym
- SinoAIADR
- Status last verified
- Sep 2020
- First submitted
- 12 Feb 2019
- Last updated
- 25 Sep 2020
- 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 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoma Detection Rate Using Artificial Intelligence System in China
- ClinicalTrials.gov ID
- NCT03840590
- Acronym / sponsor ID
- SinoAIADR / SINOCOLO2019B
- Conditions
- Colorectal Neoplasms, Colonic Polyp, Adenoma
- Keywords
- adenoma detection rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Shanghai Zhongshan Hospital, Tianjin People's Hospital, Tianjin Nankai Hospital
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 15 Feb 2019 (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.
The primary aim of this study is
- to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence is used.
Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Detailed description
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".
A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there is a significant improvement in detection of adenomas when the system is used. This study will randomize patients coming for colonoscopy to have their procedure performed as usual or as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 4 centers, recruiting a total of 800 participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.
| Arm | Type | Receives |
|---|---|---|
| AI-assisted Colonoscopy | Experimental | Device: CSK AI systemParticipants in this arm undergo AI-assisted colonoscopy using CSK AI system. |
| Standard Colonoscopy | Active comparator | Device: Standard ColonoscopyParticipants in this arm undergo standard colonoscopy. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients referred for screening, surveillance, or diagnostic colonoscopy
- All patients must be able to give informed consent
Key exclusion criteria (10 listed)
- Patients with any absolute contraindications to colonoscopy
- Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
- Patients with known colon cancer or polyposis syndromes
- Patients with known colonic strictures
- Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
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 |
|---|---|---|
| CSK AI systemCSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear. | Device | AI-assisted Colonoscopy |
| Standard ColonoscopyThis is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine. | Device | Standard Colonoscopy |
Primary outcome
Adenoma detection rate, ADR
Time frame: At the end of the procedure, up to 1 hour.
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
1 secondary outcome
Polyp detection rate, PDR
Time frame: At the end of the procedure, up to 1 hour.
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 25 Sep 2020.
- 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.
En-Da YU, MD principal investigator
Changhai Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSK AI system and Standard Colonoscopy in people with Colorectal Neoplasms and Colonic Polyp, run by Changhai Hospital at 4 sites in China.
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 10 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Adenoma detection rate, ADR (time frame: At the end of the procedure, up to 1 hour.). 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 25 Sep 2020; AzTrials last refreshed its copy on 31 Oct 2026.