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Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms

Artificial Intelligence - Assisted Colonoscopy in Diagnosis of Colorectal Neoplasms: Russian Multicenter Randomised Open - Label Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06469671
Acronym
ArtInCol
Enrollment
1000
Registered
2024-06-21
Start date
2024-07-31
Completion date
2024-12-31
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Colonic Polyp, Diagnosis

Brief 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.

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;

Interventions

DEVICEThe system based on real - time artificial intelligence - assisted for colonoscopy

Russian medical decision support system based on artificial intelligence ArtInCol

Sponsors

State Scientific Centre of Coloproctology, Russian Federation
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Screening coloscopy is needed

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Adenoma detection rateduring the procedureIn each group, the percentage of patients with at least one histologically proven adenoma or carcinoma

Secondary

MeasureTime frameDescription
Polyps detection rateduring the procedureIn each group, the number of patients with all type of neoplasms (polyps) was detected as a percentage of the total number of patients.
Number of polypsduring the procedureIn each group, the number of detected all type of polyps
Number of adenomasduring the procedureIn each group, the number of detected adenomas

Countries

Russia

Contacts

Primary ContactDmitriy Shakhmatov
mma02@yandex.ru+79035651441
Backup ContactAirat Mingazov
ajr.mingazof@gmail.com89276951752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026