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Trial Title:
Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms
NCT ID:
NCT06469671
Condition:
Colonic Neoplasms
Colonic Polyp
Diagnosis
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Colonic Neoplasms
Disease
Colonic Polyps
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
The system based on real - time artificial intelligence - assisted for colonoscopy
Description:
Russian medical decision support system based on artificial intelligence "ArtInCol"
Arm group label:
Artificial intelligence - assisted colonoscopy
Arm group label:
Conventional colonoscopy
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;
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Screening coloscopy is needed
Exclusion Criteria:
- Indications for colonoscopy
- Previously detected colorectal neoplasms
- Previously performed colorectal surgery
- Colorectal cancer
- Inflammatory bowel disease
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Airat Mingazov
Address:
City:
Moscow
Country:
Russian Federation
Contact:
Last name:
Airat Mingazov
Phone:
89276951752
Email:
ajr.mingazof@gmail.com
Contact backup:
Phone ext:
Achkasov
Email:
achkasovy@mail.ru
Investigator:
Last name:
Sergey Achkasov
Email:
Principal Investigator
Investigator:
Last name:
Dmitriy Shakhmatov
Email:
Sub-Investigator
Investigator:
Last name:
Alexey Likutov
Email:
Sub-Investigator
Investigator:
Last name:
Airat Mingazov
Email:
Sub-Investigator
Investigator:
Last name:
Ilya Nazarov
Email:
Sub-Investigator
Start date:
July 2024
Completion date:
December 2024
Lead sponsor:
Agency:
State Scientific Centre of Coloproctology, Russian Federation
Agency class:
Other
Source:
State Scientific Centre of Coloproctology, Russian Federation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06469671
