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)

NCT07502469 | Completed

• 1 other identifier: BENEFIT
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 1

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.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate (ADR)

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

  one day

Study Arms (2)

Colonoscopy performed in high-definition white light with CAD-Eye

Procedure: Colonoscopy

Colonoscopy performed with the combined use of AI/balloon (CAD-Eye/G-Eye)

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

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

Colonoscopy performed in high-definition white light with CAD-Eye; Colonoscopy performed with the combined use of AI/balloon (CAD-Eye/G-Eye)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique Saint-françois

Châteauroux, 36000, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: March 31, 2026
• Study Start: November 5, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)