Adenoma ColonACCENDO-ColoNCT05862948
Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy
A study testing ENDO-Aid by Olympus in people with Adenoma Colon and Colonic Adenoma, run by Fondazione Poliambulanza Istituto Ospedaliero at 2 sites in Italy.
Trial summary
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adenoma Colon, Colonic Adenoma
- What is being tested?
- ENDO-Aid by Olympus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Oct 2021to 30 Apr 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years or ≤85
- Patients undergoing screening, follow-up, or diagnostic colonoscopy
Who cannot join
- Suspected or known inflammatory bowel disease
- Colonic resection
- Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
- Patients with incomplete colonoscopy
- Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
- Inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione Poliambulanza
Brescia, Bs, 25124
Policlinico Universitario Agostino Gemelli
Roma, 00168
About this study
Official title: Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy - ACCENDO-Colo Study
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
- Conditions
- Adenoma Colon, Colonic Adenoma
- Being tested
- ENDO-Aid by Olympus
- Keywords
- ADR, CADe, Endo-AID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO-Aid by OlympusDevice
Colonoscopy assisted by ENDO-AID device
| Study group | Role | What they receive |
|---|---|---|
| CADe Colonoscopy | Experimental | Colonoscopy with the help of CADe system (ENDO-Aid) Receives: Device: ENDO-Aid by Olympus |
| Conventional Colonoscopy | No intervention | Standard Colonoscopy with white light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate (ADR)
ADR defined as the proportion of patients with at least 1 adenoma detected.
Measured: 1 years
Secondary outcomes (5)
Polyp detection rate (PDR)
PDR defined as the proportion of patients with at least 1 polyp detected.
Measured: 1 years
Polyp per colonoscopy (PPC)
PPC defined as total number of polyps resected divided by the total number of colonoscopies.
Measured: 1 years
Adenoma per colonoscopy (APC)
APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Measured: 1 years
Sessile serrated lesion detection rate (SSLDR)
SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies.
Measured: 1 years
Advanced adenoma detection rate (AADR)
AADR Adenomas are classified as advanced with a size >= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD)
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start30 Oct 2021
- Primary completion31 Mar 2023
- Study completion30 Apr 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 Adenoma ColonStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862948
- Sponsor's protocol ID
- NP4834
- Acronym
- ACCENDO-Colo
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spada C, Salvi D, Ferrari C, Hassan C, Barbaro F, Belluardo N, Grazioli LM, Milluzzo SM, Olivari N, Papparella LG, Pecere S, Pesatori EV, Petruzziello L, Piccirelli S, Quadarella A, Cesaro P, Costamagna G. A comprehensive RCT in screening, surveillance, and diagnostic AI-assisted colonoscopies (ACCENDO-Colo study). Dig Liver Dis. 2025 Mar;57(3):762-769. doi: 10.1016/j.dld.2024.12.023. Epub 2025 Jan 14.
PubMed 39814659
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy - ACCENDO-Colo Study
- ClinicalTrials.gov ID
- NCT05862948
- Acronym / sponsor ID
- ACCENDO-Colo / NP4834
- Conditions
- Adenoma Colon, Colonic Adenoma
- Keywords
- ADR, CADe, Endo-AID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 17 May 2023 (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 goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CADe Colonoscopy | Experimental | Device: ENDO-Aid by OlympusColonoscopy with the help of CADe system (ENDO-Aid) |
| Conventional Colonoscopy | No intervention | –Standard Colonoscopy with white light |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years or ≤85
- Patients undergoing screening, follow-up, or diagnostic colonoscopy
Key exclusion criteria (6 listed)
- Suspected or known inflammatory bowel disease
- Colonic resection
- Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
- Patients with incomplete colonoscopy
- Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
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 |
|---|---|---|
| ENDO-Aid by OlympusColonoscopy assisted by ENDO-AID device | Device | CADe Colonoscopy |
Primary outcome
Adenoma detection rate (ADR)
Time frame: 1 years
ADR defined as the proportion of patients with at least 1 adenoma detected.
5 secondary outcomes
Polyp detection rate (PDR)
Time frame: 1 years
Polyp per colonoscopy (PPC)
Time frame: 1 years
Adenoma per colonoscopy (APC)
Time frame: 1 years
Sessile serrated lesion detection rate (SSLDR)
Time frame: 1 years
Advanced adenoma detection rate (AADR)
Time frame: 1 years
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 17 May 2023.
- Derived from this study: PubMed 39814659Spada C, Salvi D, Ferrari C, Hassan C, Barbaro F, Belluardo N, Grazioli LM, Milluzzo SM, Olivari N, Papparella LG, Pecere S, Pesatori EV, Petruzziello L, Piccirelli S, Quadarella A, Cesaro P, Costamagna G. A comprehensive RCT in screening, surveillance, and diagnostic AI-assisted colonoscopies (ACCENDO-Colo study). Dig Liver Dis. 2025 Mar;57(3):762-769. doi: 10.1016/j.dld.2024.12.023. Epub 2025 Jan 14.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDO-Aid by Olympus in people with Adenoma Colon and Colonic Adenoma, run by Fondazione Poliambulanza Istituto Ospedaliero at 2 sites in Italy.
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 6 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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: 1 years). 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 NCT05862948, 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 17 May 2023.