ClinicalTrials.gg
RecruitingNCT07299071IA-COLO 2Updated Sep 24, 2026

Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years.

An interventional study of Standard colonoscopy and Colonoscopy CADe in Colonoscopy, Colorectal Neoplasms and Intestinal Polyps, sponsored by University Hospital, Bordeaux. Recruiting at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
592
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 581 studies in Colorectal Neoplasms with a site in France — 110 open to participants now, 165 under way, 26 of them phase 3. Colorectal Neoplasms · France.

Planned enrollment
78th of 463
592 · median 152
Started
2026
with 18 others
No phase
116 of 581
25 open now
Primary completion
2031-03
later than 162 of 164 live
Registered
568th of 581
by date

Among the 581 studies in Colorectal Neoplasms with a site in France, this one is the 78th largest by planned enrollment of the 463 interventional ones that give a count, is one of 19 that started in 2026, is one of 116 with no phase, reaches primary completion later than 162 of the 164 other live ones, and was the 568th registered.

Colorectal Neoplasms

6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

110 of the 581 studies in Colorectal Neoplasms with a site in France are open now. Recruiting first, the newest first:

104 more — sign in →

All 110 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The occurrence of interval cancers after colonoscopy raises the possibility of missed lesions. High- performance computer aided diagnosis (CAD) systems have been specially designed for the detection of colorectal lesions (CAD for detection is named CADe). The use of CADe improves adenoma detection in screening colonoscopy. The potential of CADe system in reducing the rate of progression to advanced polyps or interval cancer between two colonoscopies remains still uncertain.

Read the detailed description

Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Randomization into two groups: standard colonoscopy vs. colonoscopy with CADe (CAD EYE or GENIUS) (1:1). A follow-up consultation will be scheduled one-month postcolonoscopy for delivery of histological results and then at 3 years in order to organize the next colonoscopy. As part of the study, a new control colonoscopy will be scheduled for patients with high risk of CRC at 3 years. The 3-year control colonoscopy will be performed with the CAD system for all patients. The colonoscopy will be performed by another investigator who does not know the results nor the type of the first colonoscopy (evaluator blinded). In the low-risk group, we will collect follow-up data as part of routine care, including the results of colonoscopies performed outside of the protocol

03

Conditions studied

  • Colonoscopy
  • Colorectal Neoplasms
  • Intestinal Polyps

Keywords

  • colonoscopy
  • colorectal neoplasms
  • computer aided diagnosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients over 18 years of age with indication for colonoscopy as part of a screening program, after a positive immunological (FIT) test, and/or for personal or family history of colorectal cancer and/or personal history of colonic adenomas and/or sessile serrated polyp,
  • Written signed
  • Patients covered by a health-care insurance.

Exclusion criteria

Exclusion Criteria:

  • Failed complete colonoscopy, defined by the absence of cecal intubation or identification of the terminal ileum.
  • Inadequate bowel preparation (Boston bowel preparation score \< 6, and/or least at one part of colon with score ≤ 1)
  • An infiltrative tumor was diagnosed during colonoscope insertion time, not accessible to endoscopic resection and likely to require surgical management (a procedure where part of the colon may need to be removed).
  • Patient under guardianship or protection
  • Pregnant women
  • Not fluent in French or illiterate
  • Personal history of inflammatory bowel disease
  • Personal history of genetic predisposition of CRC
  • Personal history of major colorectal surgery involving total or subtotal colectomy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
592 participants (estimated)

Study arms

  • Placebo comparator
    Standard colonoscopy

    Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has standard colonoscopy

    Procedure: Standard colonoscopy

  • Active comparator
    Colonoscopy with CADe

    Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has colonoscopy with CADe (CAD EYE or GENIUS)

    Procedure: Colonoscopy CADe

Interventions

  • ProcedureStandard colonoscopy

    Colonoscopy standard (without CADe)

  • ProcedureColonoscopy CADe

    colonoscopy with CADe

06

What researchers measure

Primary outcomes

  1. Advanced adenoma

    The proportion of patients presenting at least one advanced adenoma detected after a 3-year follow-up period. An advanced adenoma is defined as an adenoma or sessile serrate adenoma (SSL) larger than 1cm (size confirmed by the CAD system and/or size estimation by snare), and/or with high-grade dysplasia or neoplasia (confirmed by histological analysis).

    Time frame: 36 months

Secondary outcomes

  1. Number of adenoma

    Average number of adenoma or SSL (confirmed by histological analysis) detected in each patient during screening colonoscopy after a 3-year follow-up period

    Time frame: 36 months

  2. Estimation of the sensitivity of CADx

    Estimated sensitivity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.

    Time frame: Day0, 36 months

  3. Estimation of the specificity of CADx

    Estimated specificity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis.

    Time frame: DAY 0, 36 months

  4. Cost of CADe and classical colonoscopy

    The cost of CADe and classical colonoscopy will be estimated using a bottom-up micro costing approach

    Time frame: Day 0, 36 months

07

Study locations

1 of 15 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2031, 60 months after the start.

Of 899 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 60 months is above that.

Counting every sponsor, half of 956 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2025
First posted
Dec 23, 2025
StartActual
Mar 13, 2026
Primary completionEst.
Mar 2031
CompletionEst.
Mar 2031
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07299071
Responsible party
Sponsor
First posted
Dec 23, 2025
Start date
Mar 13, 2026
Primary completion
Mar 2031 (estimated)
Completion
Mar 2031 (estimated)
Last update
Sep 24, 2026

Study contacts

Arthur BERGER, MD
Contact
arthur.berger@chu-bordeaux.fr
+335 57 67 49 31

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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