ColonoscopyIA COLONCT04921488
Interest of Artificial Intelligence in Cancer Screening Colonoscopy
A study testing screening colonoscopy in people with Colonoscopy and Colorectal Neoplasms, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
Artificial Intelligence (AI) to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. This new and innovative non-invasive technology will improve the quality of screening colonoscopies, and reduce the costs of colorectal cancer screening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Colorectal Neoplasms, Intestinal Polyps
- What is being tested?
- screening colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Oct 2021to 25 Jan 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with indication for colonoscopy as part of a screening colonoscopy, after a positive immunological test, and/or for personal or family history of colon cancer (before 60 years), personal history of colonic adenoma.
- Patient with at least one polyp detected, resect and removed during colonoscopy, for histological analysis
Who cannot join
- Guardianship or protection,
- pregnancy,
- not fluent in French or illiterate,
- lack of health care
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU d'Angers
Angers, 49100
Hopital Américain
Neuilly-sur-Seine, 92200
Hôpital Saint Antoine
Paris, 75012
Hôpital Européen Georges Pompidou
Paris, 75015
Centre Hospitalier Universitaire de Bordeaux
Talence, 33404
About this study
Official title: Cross-sectional, Multi-center Study Comparing Diagnostic Performance Between the CAD EYE System and the Physician on Histological Prediction of Colonic Polyps in Screening of Colorectal Cancer by Colonoscopy
Artificial Intelligence (AI) to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. This new and innovative non-invasive technology will improve the quality of screening colonoscopies, and reduce the costs of colorectal cancer screening. The aim of the study is to performed a cross-sectional, multi-center study evaluating the diagnostic performance of the CAD EYE automatic characterization system for the histology of colonic polyps in colorectal cancer screening colonoscopy.
Read the detailed description
Deep learning to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. Meanwhile, the concept of 'optical biopsy' where in vivo classification of polyps based on enhanced imaging replaces histopathology has not been incorporated into routine practice, largely limited by inter-observer variability and generally meeting accepted standards only in expert settings. Real-time decision support software has been developed to detect and characterise polyps, whilst also offering feedback on the technical quality of inspection.
This study will evaluate the performance of the CAD EYE automatic characterization system for the histology compared to histological analysis. And secondary aims : the diagnostic performance of the CAD EYE automated detection device compared to a standardized video recording with blind independent review.
Procedure: The screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE.
Follow-up: no specific follow-up is planned after colposcopy
- Conditions
- Colonoscopy, Colorectal Neoplasms, Intestinal Polyps, Deep Learning
- Being tested
- screening colonoscopy
- Keywords
- Colonoscopy, Colorectal Neoplasms, Computer aided diagnosis, Deep Learning
- Medical subject headings
- Colorectal Neoplasms, Intestinal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening colonoscopyDevice
The screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE.
| Study group | Role | What they receive |
|---|---|---|
| Patients with indication for colonoscopy | Experimental | The screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE. Receives: Device: screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the sensitivity of the automatic characterization system CAD EYE.
Estimation of the sensitivity of the automatic characterization system CAD EYE for the diagnosis of the malignant character of colonic polyps.
The sensitivity is calculated as the proportion of polyps detected by the CAD EYE characterization system among all the polyps that will be classified as malignant by the pathological analysis.The sensitivity estimate will be accompanied by its two-sided 95% confidence interval according to the exact binomial distribution. The estimated proportion will be compared with the theoretical value of 85% (minimum level from which this new technique is considered to be of interest) by a unilateral Chi2 test if the validity conditions are met or by an exact Fisher test, at 2.5% alpha threshold.
Measured: Inclusion date (date of the colonoscopy)
Secondary outcomes (3)
Estimation of the CAD EYE specificity
proportion of polyps not detected by the CAD EYE characterization system among all polyps that will be classified as benign by pathological analysis calculated, as with two-sided 95% confidence interval according to the exact binomial distribution
Measured: Inclusion date (date of the colonoscopy)
Comparison of the average number of polyps detected per patient between a colonoscopy assisted by the CAD EYE system and a colonoscopy performed without this assistance.
the average number of polyps detected per patient with the CAD EYE system will be compared to that observed by the investigator performing the colorectal cancer screening colonoscopy using a Student's t test or Wilcoxon rank test according to the distribution of the judgment criterion.
Measured: Inclusion date (date of the colonoscopy)
Compare the diagnostic performance to determine the malignancy of polyps between the automated colonic polyp detection device by the CAD EYE system, and the investigator performing the colonoscopy for colorectal cancer screening.
the reference test is the pathological examination of colonic polyps. The sensitivity of the CAD EYE system will be compared to that observed with the investigator performing the colonoscopy for colorectal cancer screening using a Chi2 test or Fisher's exact test (depending on the conditions of validity of the tests).
Measured: Inclusion date (date of the colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start21 Oct 2021
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with indication for colonoscopy as part of a screening colonoscopy.
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921488
- Sponsor's protocol ID
- CHUBX 2020/46
- Other IDs
- 2021-A00577-34
- Acronym
- IA COLO
- Status last verified
- Mar 2023
- First submitted
- 4 Jun 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maigne M, Saunier M, Renaudeau V, Dray X, Guilloux A, Cesbron-Metivier E, Olivier A, Rahmi G, Perrod G, Samaha E, Smith D, Rullier A, Zerbib F, Benard A, Berger A. Real-Time Characterization of Colonic Polyps: A Multicenter Prospective Study Evaluating the CAD-EYE System in Screening Colonoscopies. Clin Transl Gastroenterol. 2026 Mar 1;17(3):e00976. doi: 10.14309/ctg.0000000000000976.
PubMed 41563136
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional, Multi-center Study Comparing Diagnostic Performance Between the CAD EYE System and the Physician on Histological Prediction of Colonic Polyps in Screening of Colorectal Cancer by Colonoscopy
- ClinicalTrials.gov ID
- NCT04921488
- Acronym / sponsor ID
- IA COLO / CHUBX 2020/46
- Conditions
- Colonoscopy, Colorectal Neoplasms, Intestinal Polyps, Deep Learning
- Keywords
- Colonoscopy, Colorectal Neoplasms, Computer aided diagnosis, Deep Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 10 Jun 2021 (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.
Artificial Intelligence (AI) to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. This new and innovative non-invasive technology will improve the quality of screening colonoscopies, and reduce the costs of colorectal cancer screening. The aim of the study is to performed a cross-sectional, multi-center study evaluating the diagnostic performance of the CAD EYE automatic characterization system for the histology of colonic polyps in colorectal cancer screening colonoscopy.
Detailed description
Deep learning to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. Meanwhile, the concept of 'optical biopsy' where in vivo classification of polyps based on enhanced imaging replaces histopathology has not been incorporated into routine practice, largely limited by inter-observer variability and generally meeting accepted standards only in expert settings. Real-time decision support software has been developed to detect and characterise polyps, whilst also offering feedback on the technical quality of inspection.
This study will evaluate the performance of the CAD EYE automatic characterization system for the histology compared to histological analysis. And secondary aims : the diagnostic performance of the CAD EYE automated detection device compared to a standardized video recording with blind independent review.
Procedure: The screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE.
Follow-up: no specific follow-up is planned after colposcopy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with indication for colonoscopy as part of a screening colonoscopy.
| Arm | Type | Receives |
|---|---|---|
| Patients with indication for colonoscopy | Experimental | Device: screening colonoscopyThe screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age with indication for colonoscopy as part of a screening colonoscopy, after a positive immunological test, and/or for personal or family history of colon cancer (before 60 years), personal history of colonic adenoma.
- Patient with at least one polyp detected, resect and removed during colonoscopy, for histological analysis
Key exclusion criteria (4 listed)
- Guardianship or protection,
- pregnancy,
- not fluent in French or illiterate,
- lack of health care
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 |
|---|---|---|
| screening colonoscopyThe screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE. | Device | Patients with indication for colonoscopy |
Primary outcome
Estimation of the sensitivity of the automatic characterization system CAD EYE.
Time frame: Inclusion date (date of the colonoscopy)
Estimation of the sensitivity of the automatic characterization system CAD EYE for the diagnosis of the malignant character of colonic polyps. The sensitivity is calculated as the proportion of polyps detected by the CAD EYE characterization system among all the polyps that will be classified as malignant by the pathological analysis.The sensitivity estimate will be accompanied by its two-sided 95% confidence interval according to the exact binomial distribution. The estimated proportion will be compared with the theoretical value of 85% (minimum level from which this new technique is considered to be of interest) by a unilateral Chi2 test if the validity conditions are met or by an exact Fisher test, at 2.5% alpha threshold.
3 secondary outcomes
Estimation of the CAD EYE specificity
Time frame: Inclusion date (date of the colonoscopy)
Comparison of the average number of polyps detected per patient between a colonoscopy assisted by the CAD EYE system and a colonoscopy performed without this assistance.
Time frame: Inclusion date (date of the colonoscopy)
Compare the diagnostic performance to determine the malignancy of polyps between the automated colonic polyp detection device by the CAD EYE system, and the investigator performing the colonoscopy for colorectal cancer screening.
Time frame: Inclusion date (date of the colonoscopy)
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 15 May 2026.
- Results publication: PubMed 41563136Maigne M, Saunier M, Renaudeau V, Dray X, Guilloux A, Cesbron-Metivier E, Olivier A, Rahmi G, Perrod G, Samaha E, Smith D, Rullier A, Zerbib F, Benard A, Berger A. Real-Time Characterization of Colonic Polyps: A Multicenter Prospective Study Evaluating the CAD-EYE System in Screening Colonoscopies. Clin Transl Gastroenterol. 2026 Mar 1;17(3):e00976. doi: 10.14309/ctg.0000000000000976.
- Individual participant dataSharing planned: No
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening colonoscopy in people with Colonoscopy and Colorectal Neoplasms, run by University Hospital, Bordeaux at 5 sites 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 2 inclusion and 4 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Estimation of the sensitivity of the automatic characterization system CAD EYE. (time frame: Inclusion date (date of the colonoscopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921488, which also lists 1 linked publication.
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 15 May 2026.