Colonic NeoplasmsArtInColNCT06469671
Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms
A study testing The system based on real - time artificial intelligence - assisted for colonoscopy in people with Colonic Neoplasms and Colonic Polyp, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Neoplasms, Colonic Polyp, Diagnosis
- What is being tested?
- The system based on real - time artificial intelligence - assisted for colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2024to Dec 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening coloscopy is needed
Who cannot join
- Indications for colonoscopy
- Previously detected colorectal neoplasms
- Previously performed colorectal surgery
- Colorectal cancer
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Russia1 site
Airat Mingazov
Moscow
Airat Mingazov, 89276951752, ajr.mingazof@gmail.com
achkasovy@mail.ru
About this study
Official title: Artificial Intelligence - Assisted Colonoscopy in Diagnosis of Colorectal Neoplasms: Russian Multicenter Randomised Open - Label Trial
The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.
Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.
Read the detailed description
The primary outcome is adenoma detection rate per patient.
The secondary outcomes will be measured:
- Polyps detection rate (all type of lesions) per patient;
- Number of adenomas per patient;
- Number of polyps per patient;
- Conditions
- Colonic Neoplasms, Colonic Polyp, Diagnosis
- Being tested
- The system based on real - time artificial intelligence - assisted for colonoscopy
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The system based on real - time artificial intelligence - assisted for colonoscopyDevice
Russian medical decision support system based on artificial intelligence "ArtInCol"
| Study group | Role | What they receive |
|---|---|---|
| Artificial intelligence - assisted colonoscopy | Experimental | The decision making system based on artificial intelligence. Real - time artificial intelligence - assisted colonoscopy will be performed in this group.
Detection of polyps is based on real time fixing a frame on the screen. Receives: Device: The system based on real - time artificial intelligence - assisted for colonoscopy |
| Conventional colonoscopy | Active comparator | Conventional colonoscopy will be performed in this group Receives: Device: The system based on real - time artificial intelligence - assisted for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma
Measured: during the procedure
Secondary outcomes (3)
Polyps detection rate
In each group, the number of patients with all type of neoplasms (polyps) was detected as a percentage of the total number of patients.
Measured: during the procedure
Number of polyps
In each group, the number of detected all type of polyps
Measured: during the procedure
Number of adenomas
In each group, the number of detected adenomas
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 posted21 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic 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
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Achkasov, Principal investigator, State scientific centre of coloproctology, Moscow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469671
- Sponsor's protocol ID
- 7-24
- Acronym
- ArtInCol
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence - Assisted Colonoscopy in Diagnosis of Colorectal Neoplasms: Russian Multicenter Randomised Open - Label Trial
- ClinicalTrials.gov ID
- NCT06469671
- Acronym / sponsor ID
- ArtInCol / 7-24
- Conditions
- Colonic Neoplasms, Colonic Polyp, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 2024 (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 goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.
Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.
Detailed description
The primary outcome is adenoma detection rate per patient.
The secondary outcomes will be measured:
- Polyps detection rate (all type of lesions) per patient;
- Number of adenomas per patient;
- Number of polyps per patient;
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial intelligence - assisted colonoscopy | Experimental | Device: The system based on real - time artificial intelligence - assisted for colonoscopyThe decision making system based on artificial intelligence. Real - time artificial intelligence - assisted colonoscopy will be performed in this group. Detection of polyps is based on real time fixing a frame on the screen. |
| Conventional colonoscopy | Active comparator | Device: The system based on real - time artificial intelligence - assisted for colonoscopyConventional colonoscopy will be performed in this group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Screening coloscopy is needed
Key exclusion criteria (5 listed)
- Indications for colonoscopy
- Previously detected colorectal neoplasms
- Previously performed colorectal surgery
- Colorectal cancer
- Inflammatory bowel disease
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 system based on real - time artificial intelligence - assisted for colonoscopyRussian medical decision support system based on artificial intelligence "ArtInCol" | Device | Artificial intelligence - assisted colonoscopy, Conventional colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: during the procedure
In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma
3 secondary outcomes
Polyps detection rate
Time frame: during the procedure
Number of polyps
Time frame: during the procedure
Number of adenomas
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 21 Jun 2024.
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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.
Sergey Achkasov principal investigator
State scientific centre of coloproctology, Moscow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The system based on real - time artificial intelligence - assisted for colonoscopy in people with Colonic Neoplasms and Colonic Polyp, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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 5 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 21 Jun 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 Russia. 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 Dmitriy Shakhmatov (+79035651441, mma02@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (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 21 Jun 2024.