Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection

NCT06216405 | Completed DMC

• 1 other identifier: 2021-A01243-38
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess whether the use of artificial intelligence improves polyp detection in a segment of the colon (the right colon). To achieve this objective, patients will be divided into two groups: one will undergo a standard colonoscopy, the other a colonoscopy with the artificial intelligence software connected to the machine. This software does not modify the colonoscopy technique in any way, and does not require the administration of any product to the patient. The study will compare the detection rate of right colon polyps between the group of patients who underwent standard colonoscopy and those who underwent colonoscopy with artificial intelligence. If this number does not differ between the two groups, the investigators can conclude that there is no point in using artificial intelligence.

Conditions

Colon Cancer; Colon Polyp; Colon Lesion; Colon Adenocarcinoma

Keywords

Colonoscopy; Polyp detection; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale, for the operator, for the endoscope and for stratification factors.

  A multiple logistic regression comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale (6-7 vs \>7), for the operator, for the endoscope (Pentax or Fuji) and for stratification factors (age and polyps or CRC history).

  Inclusion visit

Study Arms (2)

AI-aided colonoscopy

EXPERIMENTAL

Experimental arm : patients receive a colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA)

Procedure: Colonoscopy

Standard colonoscopy

ACTIVE COMPARATOR

Control arm :The artificial intelligence is not activated during the colonoscopy exam,the patient receive a standard high definition colonoscopy

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

Colonoscopy

AI-aided colonoscopy; Standard colonoscopy

Eligibility Criteria

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

You may qualify if:

• Age\>18 years
• Signed informed consent
• Affiliated to or beneficiary of a social security scheme

You may not qualify if:

• Patients with history of inflammatory bowel diseases
• Patients with history of familial polyposis syndrome
• Patients with history of right colonic resection.
• Pregnant or breastfeeding women
• Patient benefiting from a legal protection measure : tutorship, curatorship, patient deprived of freedom
• Adults who are unable to give their consent
• People under psychiatric care who are not able to understand the aim if this research

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead
• Cosmo Artificial Intelligence-AI Ltd: collaborator

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, Île-de-France Region, 75020, France

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps

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

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A single-blind, randomised study. Patient is not informed of the arm he is assigned to.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized into the two groups: * Experimental : AI-aided colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA) * Control : Standard high-definition colonoscopy: Randomization will be established according to a 1:1 ratio, balanced and per block of variable size, and stratified according to age (≤50 vs \>50 years-old) and on personal polyps or colorectal cancer history (yes vs no)

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: January 20, 2022
• Primary Completion: December 12, 2023
• Study Completion: January 3, 2024
• Last Updated: January 23, 2024

Record last verified: 2023-03

Locations

FR (1)