Inflammatory Bowel DiseasesNCT06281392
Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)
A study testing CADe system and NBI in people with Inflammatory Bowel Diseases and Dysplasia, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Dysplasia
- What is being tested?
- CADe system and NBI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2023to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (age ≥18 years).
- Patients with IBD meeting the following criteria:
- Diagnosis of IBD confirmed by clinical and histological evidence.
- Disease extent (Montreal classification): 1) For Ulcerative Colitis (UC), Extensive colitis (E3): involvement proximal to the splenic flexure; or, Left-sided colitis (E2): involvement distal to the splenic flexure. 2) For Crohn's Disease (CD): Colon-only involvement (L2); or, Ileocolonic involvement (L3).
- Disease duration > 7 years.
- Patients with concommitant Primary Sclerosing Cholangitis, regardless of the extent of colonic involvement and disease duration.
- Written consent from the patient to undergo colonoscopy (signed informed consent).
Who cannot join
- Personal history of colorectal cancer (CRC).
- Previous colectomy (partial or complete).
- Coagulopathy preventing biopsy or polypectomy/mucosal resection.
- Colonoscopy performed in the last 6 months.
- Pregnant or lactating women.
- Ulcerative colitis with involvement limited to the rectum or Proctitis (Montreal E1).
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- Inadequate colonic preparation due to uncleavable fecal residue during colonoscopy: Boston Bowel Preparation Scale (BBPS) = 0 or 1 in any colon segment.
- Presence of inflammatory activity due to IBD on endoscopy:1) For UC: Endoscopic Mayo Score ≥ 2. 2) For CD: Simplified Endoscopic Activity Score (SES-CD) > 5.
- Incomplete lower digestive endoscopy (failure to reach the cecum).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Artificial Intelligence System on the Detection of Dysplasia During Colonoscopy in Patients With Long-standing Inflammatory Bowel Disease: a Randomized Study (EIIDISIA Study)
Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD).
- Conditions
- Inflammatory Bowel Diseases, Dysplasia
- Being tested
- CADe system, NBI
- Keywords
- Inflammatory Bowel Disease, Virtual chromoendoscopy, NBI, CADe, Dysplasia
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADe systemDevice
Colonoscopy assisted by an artificial intelligence system (CADe).
NBIDevice
Virtual colonoscopy assisted by NBI
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy assisted by CADe | Experimental | Not described Receives: Device: CADe system |
| Virtual Colonoscopy with NBI | Active comparator | Not described Receives: Device: NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Per lesion" dysplasia detection rate (DDR)
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI in patients with long-standing Inflammatory bowel disease who undergo surveillance colonoscopy
Measured: Immediately after the procedure
"Per patient" dysplasia detection rate (DDR)
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Inflammatory bowel disease included in the study detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI
Measured: Immediately after the procedure
Secondary outcomes (1)
Duration of endoscopic examination
Median (IQR) examination time (in minutes) (including total, insertion, and withdrawal time) required by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start15 Nov 2023
- Primary completion20 Jun 2025
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Antonio López-Serrano, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Antonio López-Serrano, PhD, Principal investigator, Hospital Universitari Dr. Peset, Valencia (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281392
- Sponsor's protocol ID
- CEIm: 106/23
- Status last verified
- Aug 2025
- First submitted
- 27 Nov 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Artificial Intelligence System on the Detection of Dysplasia During Colonoscopy in Patients With Long-standing Inflammatory Bowel Disease: a Randomized Study (EIIDISIA Study)
- ClinicalTrials.gov ID
- NCT06281392
- Acronym / sponsor ID
- CEIm: 106/23
- Conditions
- Inflammatory Bowel Diseases, Dysplasia
- Keywords
- Inflammatory Bowel Disease, Virtual chromoendoscopy, NBI, CADe, Dysplasia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 28 Feb 2024 (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.
Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy assisted by CADe | Experimental | Device: CADe system |
| Virtual Colonoscopy with NBI | Active comparator | Device: NBI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (age ≥18 years).
- Patients with IBD meeting the following criteria:
- Diagnosis of IBD confirmed by clinical and histological evidence.
- Disease extent (Montreal classification): 1) For Ulcerative Colitis (UC), Extensive colitis (E3): involvement proximal to the splenic flexure; or, Left-sided colitis (E2): involvement distal to the splenic flexure. 2) For Crohn's Disease (CD): Colon-only involvement (L2); or, Ileocolonic involvement (L3).
- Disease duration > 7 years.
Key exclusion criteria (9 listed)
- Personal history of colorectal cancer (CRC).
- Previous colectomy (partial or complete).
- Coagulopathy preventing biopsy or polypectomy/mucosal resection.
- Colonoscopy performed in the last 6 months.
- Pregnant or lactating women.
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 |
|---|---|---|
| CADe systemColonoscopy assisted by an artificial intelligence system (CADe). | Device | Colonoscopy assisted by CADe |
| NBIVirtual colonoscopy assisted by NBI | Device | Virtual Colonoscopy with NBI |
Primary outcome
"Per lesion" dysplasia detection rate (DDR)
Time frame: Immediately after the procedure
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI in patients with long-standing Inflammatory bowel disease who undergo surveillance colonoscopy
"Per patient" dysplasia detection rate (DDR)
Time frame: Immediately after the procedure
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Inflammatory bowel disease included in the study detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI
1 secondary outcome
Duration of endoscopic examination
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Antonio López-Serrano, PhD principal investigator
Hospital Universitari Dr. Peset, Valencia (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADe system and NBI in people with Inflammatory Bowel Diseases and Dysplasia, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
"Per lesion" dysplasia detection rate (DDR) (time frame: Immediately after the procedure). The study lists 2 primary outcomes in all. 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 15 Aug 2025.