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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)

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07502469
Acronym
BENEFIT
Enrollment
341
Registered
2026-03-31
Start date
2024-11-05
Completion date
2025-03-01
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer, Colorectal Cancer

Brief summary

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.

Interventions

PROCEDUREColonoscopy

Colonoscopy performed between November 1st 2021 and June 30th 2024

Sponsors

Elsan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adenoma Detection Rate (ADR)one dayRate of patients in which at least one adenoma was detected (between 0 and patients included - almost 300)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026