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Not yet recruitingNCT06469671ArtInColUpdated Jun 21, 2024

Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms

An interventional study of The system based on real - time artificial intelligence - assisted for colonoscopy in Colonic Neoplasms, Colonic Polyp and Diagnosis, sponsored by State Scientific Centre of Coloproctology, Russian Federation. Not yet recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by State Scientific Centre of Coloproctology, Russian Federation · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

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;
02

Conditions studied

  • Colonic Neoplasms
  • Colonic Polyp
  • Diagnosis
03

In context

Colonic Neoplasms

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation is the lead sponsor of 26 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Screening coloscopy is needed

Exclusion criteria

Exclusion Criteria:

  • Indications for colonoscopy
  • Previously detected colorectal neoplasms
  • Previously performed colorectal surgery
  • Colorectal cancer
  • Inflammatory bowel disease
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Artificial intelligence - assisted colonoscopy

    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.

    Device: The system based on real - time artificial intelligence - assisted for colonoscopy

  • Active comparator
    Conventional colonoscopy

    Conventional colonoscopy will be performed in this group

    Device: The system based on real - time artificial intelligence - assisted for colonoscopy

Interventions

  • DeviceThe system based on real - time artificial intelligence - assisted for colonoscopy

    Russian medical decision support system based on artificial intelligence "ArtInCol"

06

What researchers measure

Primary outcomes

  1. Adenoma detection rate

    In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma

    Time frame: during the procedure

Secondary outcomes

  1. 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.

    Time frame: during the procedure

  2. Number of polyps

    In each group, the number of detected all type of polyps

    Time frame: during the procedure

  3. Number of adenomas

    In each group, the number of detected adenomas

    Time frame: during the procedure

07

Study locations

1 site
  • Airat Mingazov
    Moscow, Russian Federation
    • Airat Mingazov · Contactajr.mingazof@gmail.com · 89276951752
    • · Contactachkasovy@mail.ru
    • Sergey Achkasov · Principal investigator
    • Dmitriy Shakhmatov · Sub investigator
    • Alexey Likutov · Sub investigator
    • Airat Mingazov · Sub investigator
    • Ilya Nazarov · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06469671
Lead sponsor
State Scientific Centre of Coloproctology, Russian Federation
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Jul 2024 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Jun 21, 2024

Study contacts

Dmitriy Shakhmatov
Contact
mma02@yandex.ru
+79035651441
Airat Mingazov
Contact
ajr.mingazof@gmail.com
89276951752
Sergey Achkasov
principal investigator · State scientific centre of coloproctology, Moscow

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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