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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Polyp
• Colonic Polyps
• Colorectal Neoplasms
• Diagnosis
• Disease
• Neoplasms

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