Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms

NCT06469671 | Not Yet Recruiting DMC

• 1 other identifier: 7-24
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Neoplasms; Colonic Polyp; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

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

  during the procedure

Secondary Outcomes (3)

• Polyps detection rate

  during the procedure

• Number of polyps

  during the procedure

• Number of adenomas

  during the procedure

Study Arms (2)

Artificial intelligence - assisted colonoscopy

EXPERIMENTAL

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

Conventional colonoscopy

ACTIVE COMPARATOR

Conventional colonoscopy will be performed in this group

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

Interventions

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

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

Artificial intelligence - assisted colonoscopy; Conventional colonoscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening coloscopy is needed

You may not qualify if:

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

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

Study Sites (1)

Airat Mingazov

Moscow, Russia

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps; Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Sergey Achkasov

  State scientific centre of coloproctology, Moscow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitriy Shakhmatov

CONTACT

+79035651441; mma02@yandex.ru

Airat Mingazov

CONTACT

89276951752; ajr.mingazof@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

RU (1)