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OpenTrials
Completed

NCT Number: NCT07502469

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)

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Procedure

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

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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.

Acronym: BENEFIT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.