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)

March 26, 2026 updated by: Elsan

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

341

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: one day
Rate of patients in which at least one adenoma was detected (between 0 and patients included - almost 300)
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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