Colorectal CancerBENEFITNCT07502469
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)
An observational study of Colorectal Cancer and Colo-rectal Cancer, run by Elsan at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer, Colo-rectal Cancer
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 341 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read more
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
- Colorectal Cancer, Colo-rectal Cancer
- Being tested
- Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Colonoscopy performed between November 1st 2021 and June 30th 2024
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy performed in high-definition white light with CAD-Eye | Not described Receives: Procedure: Colonoscopy | |
| Colonoscopy performed with the combined use of AI/balloon (CAD-Eye/G-Eye) | Not described Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
Rate of patients in which at least one adenoma was detected (between 0 and patients included - almost 300)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start5 Nov 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502469
- Sponsor's protocol ID
- BENEFIT
- Acronym
- BENEFIT
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07502469
- Acronym / sponsor ID
- BENEFIT / BENEFIT
- Conditions
- Colorectal Cancer, Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyColonoscopy performed between November 1st 2021 and June 30th 2024 | Procedure or surgery | Colonoscopy performed in high-definition white light with CAD-Eye, Colonoscopy performed with the combined use of AI/balloon (CAD-Eye/G-Eye) |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colo-rectal Cancer, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (ADR) (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.