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NCT06469671 Clinical Trial

Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms

Colonic Neoplasms Clinical Trial

— ArtInCol  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06469671
Other study ID # 7-24
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date December 2024

Study information
Verified date June 2024
Source State Scientific Centre of Coloproctology, Russian Federation
Contact Dmitriy Shakhmatov
Phone +79035651441
Email mma02@yandex.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.

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;

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Screening coloscopy is needed Exclusion Criteria: - Indications for colonoscopy - Previously detected colorectal neoplasms - Previously performed colorectal surgery - Colorectal cancer - Inflammatory bowel disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• The system based on real - time artificial intelligence - assisted for colonoscopy
Russian medical decision support system based on artificial intelligence "ArtInCol"

Locations
Country Name City State
Russian Federation Airat Mingazov Moscow

Sponsors (1)
Lead Sponsor Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adenoma detection rate In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma during the procedure
Secondary 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. during the procedure
Secondary Number of polyps In each group, the number of detected all type of polyps during the procedure
Secondary Number of adenomas In each group, the number of detected adenomas during the procedure
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