Study Comparing the Contribution of G-Eye Combined With CAD-Eye Versus High-definition Colonoscopy With CAD-Eye in the Detection of Colonic Lesions After a Positive Immunological Test in the Context of Organized Colorectal Cancer (BENEFIT) (BENEFIT)

Single-center, Retrospective Study Comparing the Contribution of G-Eye (Balloon-assisted Endoscopy) Combined With CAD-Eye (Artificial Intelligence Polyp Detection) Versus High-definition Colonoscopy With CAD-Eye in the Detection of Colonic Lesions After a Positive Immunological Test in the Context of Organized Colorectal Cancer Screening.

The incidence of colorectal cancer (CRC) is high in France, with approximately 45,000 new cases per year. The fecal immunochemical test (FIT) is used for screening for this cancer. If the test is positive, a colonoscopy is recommended.

In recent years, French and European societies of digestive endoscopy have defined quality criteria for colonoscopy to reduce the risk of interval colorectal cancer (ICRC), that is, CRC occurring within 5 years of a colonoscopy considered negative. The operator's adenoma detection rate (ADR) is one of these factors. Its threshold is set at 45% within the framework of the organized CRC screening program, i.e., after a positive FIT.

Artificial intelligence is emerging as an effective way to increase operators' ADR. Balloon-assisted endoscopy (G-Eye) also increases the TDA (transient anaerobic digestion).

No French data are available regarding G-Eye, and there is limited data concerning CAD-Eye (artificial intelligence). No data exist on the combination of these two devices. Therefore, there is no data on the combination of these devices during a colonoscopy performed after a positive TIF (transient anaerobic digestion) test.

It should be noted that all published studies were conducted in expert centers. The value of this study lies in its ability to collect real-world data.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colo-rectal Cancer
• Intervention / Treatment: Procedure: Colonoscopy

• Study Type: Observational
• Enrollment (Actual): 341

Contacts and Locations

Study Locations

• France
  • Châteauroux, France, 36000
    • Clinique Saint-françois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult between 50 and 74 years old who performed a colonoscopy at Clinique St François (Chateauroux) between November 1, 2021 and June 30, 2024

Description

Inclusion Criteria:

• Fecal Immunological Test positive
• Age between 50 and 74 years
• Colonoscopy performed between November 1, 2021 and June 30, 2024
• Patient informed about the use of their health data

Exclusion Criteria:

• High or very high risk of colorectal cancer (CRC) (inflammatory bowel disease, identified genetic predisposition to CRC, personal history of CRC, advanced adenoma < 10 years, first-degree family history of CRC < 60 years)
• Patient < 50 years and > 74 years
• Patient opposed to the reuse of their health data

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colonoscopy performed in high-definition white light with CAD-Eye	Procedure: Colonoscopy; Colonoscopy performed between November 1st 2021 and June 30th 2024
Colonoscopy performed with the combined use of AI/balloon (CAD-Eye/G-Eye)	Procedure: Colonoscopy; Colonoscopy performed between November 1st 2021 and June 30th 2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate (ADR)	Rate of patients in which at least one adenoma was detected (between 0 and patients included - almost 300)	one day

Collaborators and Investigators

• Sponsor: Elsan

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Colonic Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Colonoscopy
• Other Study ID Numbers: BENEFIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No