PolypsCADDIENCT04325815
CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy
An observational study of Polyps and Adenoma Colon, run by University College, London at 1 site in United Kingdom.
Trial summary
Background: Colonoscopy is accepted to be the gold standard for screening of colorectal cancer (CRC). Most CRCs develop from adenomatous polyps, with colonoscopy accepted to be the gold standard for screening of CRC. An endoscopist's ability to detect polyps is assessed in the form of an Adenoma Detection Rate (ADR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyps, Adenoma Colon, Colorectal Polyp
- What is being tested?
- CADDIE- Computer Aided (AI) Device used in Endoscopy
- Type of treatment
- Medical device
- How many people
- 739 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2021to 8 Mar 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Study population will include patient's scheduled to undergo a surveillance or symptomatic colonoscopy at the participating sites.
Who may be able to join
- Patient's scheduled to undergo a surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial.
- Male and female participants aged 18 years or older at the time of informed consent.
- Patient's able to comprehend, sign and date the written informed consent document to participate in the study.
Who cannot join
- Emergency colonoscopies and/or inpatient colonoscopies.
- Patients with inflammatory bowel disease (IBD)
- Patients with Colorectal Cancer (CRC)
- Patients with previous CRC
- Patients with previous colonic resection
- Patients returning for a planned elective therapeutic colonoscopy.
Show all 12Show fewer
- Polyposis syndromes
- Current or relevant history of a physical or psychiatric illness or any medical condition that in the opinion of the investigator could affect the patient's safety or interfere with the study assessments
- Patients with a contraindication for biopsy or polypectomy. These include:
- Patients who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines 30.
- Patients with a history of haemostasis disorders (Haemostasis disorders will include but will not be limited to: patients with haemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders).
- Patients is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Centre, Open-label, Randomised, Prospective Trial to Assess Efficacy and Safety of the CADDIE Artificial Intelligence System for Improving Endoscopic Detection of Colonic Polyps in Real-time.
Background:
Colonoscopy is accepted to be the gold standard for screening of colorectal cancer (CRC). Most CRCs develop from adenomatous polyps, with colonoscopy accepted to be the gold standard for screening of CRC. An endoscopist's ability to detect polyps is assessed in the form of an Adenoma Detection Rate (ADR). Each 1.0% increase in ADR is associated with a 3.0% decrease in the risk of the patient developing an interval CRC. There remains a wide variation in endoscopist ADR.
Read more
More recently, the use of artificial intelligence (AI) and computer aided diagnosis in endoscopy has been gaining increasing attention for its role in automated lesion detection and characterisation. AI can potentially improve ADR, but previous AI related work has largely focused on retrospectively assessing still endoscopic images and selected video sequences which may be subject to bias and lack clinical utility. There are only limited clinical studies evaluating the effect of AI in improving ADR.
The CADDIE device uses convolutional neural networks developed for computer assisted detection and computer assisted diagnosis of polyps.
Primary objective: To determine whether the CADDIE artificial intelligence system improves endoscopic detection of adenomas during colonoscopy.
Primary endpoint: The difference in adenoma detection rate (ADR) between the intervention (supported with the CADDIE system) and non-intervention arm
Study design: Multi-Centre, open-label, randomised, prospective trial to assess efficacy and safety of the CADDIE artificial intelligence system for improving endoscopic detection of colonic polyps in real-time.
- Conditions
- Polyps, Adenoma Colon, Colorectal Polyp, Colon Polyp
- Being tested
- CADDIE- Computer Aided (AI) Device used in Endoscopy
- Keywords
- Artificial Intelligence, Endoscopy, ADR
- Medical subject headings
- Polyps, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADDIE- Computer Aided (AI) Device used in EndoscopyDevice
- CADDIE assisted polyp detection
- CADDIE assisted polyp characterisation
| Study group | Role | What they receive |
|---|---|---|
| CADDIE | The endoscopist will be assisted with CADDIE system to detect polyps. The endoscopist will perform optical diagnosis of polyps with the assistance of the CADDIE's polyp characterisation function. Receives: Device: CADDIE- Computer Aided (AI) Device used in Endoscopy | |
| Standard Procedure | In addition to routine colonoscopy the endoscopist will perform optical diagnosis of detected polyps without the assistance of the CADDIE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate Whether Using the CADDIE System Improves Endoscopist Detection of Adenomas During Colonoscopy.
The difference in endoscopist ADR between the intervention (CADDIE system) and non-intervention arm.
Measured: 30 days
Secondary outcomes (7)
Evaluate the Difference in Number of Adenomas Detected Per Colonoscopy Between Intervention and Non-intervention Arm
Compare the difference in the number of adenomas detected per colonoscopy between the intervention and non-intervention arm
Measured: 30 days
To Determine Whether the CADDIE Artificial Intelligence System Improves Endoscopic Detection of All Polyps During Colonoscopy
Polyp Detection Rate (including proximal polyp detection rate) in the interventional group compared to the control group.
- Mean number of polyps detected per colonoscopy in the interventional group compared to the control group.
Measured: 30 days
Compare the Accuracy of Endoscopist Optical Diagnosis of Diminutive Polyps When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)
Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive polyps. Accuracy is defined as true positive and true negative divided by diagnoses total polyps that were optically diagnosed with high confidence.
Measured: 30 days
Compare the Accuracy of Endoscopist Optical Diagnosis to Assign Colonoscopy Surveillance Intervals When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)
Compare the accuracy of using CADDIE's optical diagnosis to assign surveillance colonoscopy intervals against using human endoscopist optical diagnosis (high confidence diagnoses) for assigning surveillance colonoscopy intervals.
Measured: 30 days
Compare the Accuracy of Endoscopist Optical Diagnosis of Diminutive Rectal Polyps When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)
Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive rectal polyps.
Measured: 30 days
Evaluate the Safety of the CADDIE by Recording Occurrence and Severity of Adverse Events.
Safety of the device will be assessed through monitoring of adverse events for 30 days' post-procedure. Adverse events are defined as:
- Abdominal pain/discomfort.
- Abdominal bloating.
- Sedation related aspiration.
- Bleeding risk.
- Perforation.
- Post polypectomy electrocoagulation syndrome.
- Infection.
Measured: 30 days
Assess Patient Anxiety During the Colonoscopy
Patient response to the question 'How anxious or calm were you during the colonoscopy?' assessed by Likert Scale with 5 options - 1 (Very anxious), 2 (Somewhat anxious), 3 (Neither Anxious nor calm), 4 (Somewhat calm), 5 (Very calm).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start29 Apr 2021
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PolypsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Chand, MBBS FRCS PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325815
- Sponsor's protocol ID
- 126166
- Acronym
- CADDIE
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2020
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients will be asked informed consent with the possibility to share the data
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre, Open-label, Randomised, Prospective Trial to Assess Efficacy and Safety of the CADDIE Artificial Intelligence System for Improving Endoscopic Detection of Colonic Polyps in Real-time.
- ClinicalTrials.gov ID
- NCT04325815
- Acronym / sponsor ID
- CADDIE / 126166
- Conditions
- Polyps, Adenoma Colon, Colorectal Polyp, Colon Polyp
- Keywords
- Artificial Intelligence, Endoscopy, ADR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Posted 19 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Colonoscopy is accepted to be the gold standard for screening of colorectal cancer (CRC). Most CRCs develop from adenomatous polyps, with colonoscopy accepted to be the gold standard for screening of CRC. An endoscopist's ability to detect polyps is assessed in the form of an Adenoma Detection Rate (ADR). Each 1.0% increase in ADR is associated with a 3.0% decrease in the risk of the patient developing an interval CRC. There remains a wide variation in endoscopist ADR.
More recently, the use of artificial intelligence (AI) and computer aided diagnosis in endoscopy has been gaining increasing attention for its role in automated lesion detection and characterisation. AI can potentially improve ADR, but previous AI related work has largely focused on retrospectively assessing still endoscopic images and selected video sequences which may be subject to bias and lack clinical utility. There are only limited clinical studies evaluating the effect of AI in improving ADR.
The CADDIE device uses convolutional neural networks developed for computer assisted detection and computer assisted diagnosis of polyps.
Primary objective: To determine whether the CADDIE artificial intelligence system improves endoscopic detection of adenomas during colonoscopy.
Primary endpoint: The difference in adenoma detection rate (ADR) between the intervention (supported with the CADDIE system) and non-intervention arm
Study design: Multi-Centre, open-label, randomised, prospective trial to assess efficacy and safety of the CADDIE artificial intelligence system for improving endoscopic detection of colonic polyps in real-time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CADDIE | – | Device: CADDIE- Computer Aided (AI) Device used in EndoscopyThe endoscopist will be assisted with CADDIE system to detect polyps. The endoscopist will perform optical diagnosis of polyps with the assistance of the CADDIE's polyp characterisation function. |
| Standard Procedure | – | –In addition to routine colonoscopy the endoscopist will perform optical diagnosis of detected polyps without the assistance of the CADDIE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include patient's scheduled to undergo a surveillance or symptomatic colonoscopy at the participating sites.
Key inclusion criteria (3 listed)
- Patient's scheduled to undergo a surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial.
- Male and female participants aged 18 years or older at the time of informed consent.
- Patient's able to comprehend, sign and date the written informed consent document to participate in the study.
Key exclusion criteria (12 listed)
- Emergency colonoscopies and/or inpatient colonoscopies.
- Patients with inflammatory bowel disease (IBD)
- Patients with Colorectal Cancer (CRC)
- Patients with previous CRC
- Patients with previous colonic resection
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 |
|---|---|---|
| CADDIE- Computer Aided (AI) Device used in Endoscopy1. CADDIE assisted polyp detection 2. CADDIE assisted polyp characterisation | Device | CADDIE |
Primary outcome
To Evaluate Whether Using the CADDIE System Improves Endoscopist Detection of Adenomas During Colonoscopy.
Time frame: 30 days
The difference in endoscopist ADR between the intervention (CADDIE system) and non-intervention arm.
7 secondary outcomes
Evaluate the Difference in Number of Adenomas Detected Per Colonoscopy Between Intervention and Non-intervention Arm
Time frame: 30 days
To Determine Whether the CADDIE Artificial Intelligence System Improves Endoscopic Detection of All Polyps During Colonoscopy
Time frame: 30 days
Compare the Accuracy of Endoscopist Optical Diagnosis of Diminutive Polyps When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)
Time frame: 30 days
Compare the Accuracy of Endoscopist Optical Diagnosis to Assign Colonoscopy Surveillance Intervals When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)
Time frame: 30 days
Compare the Accuracy of Endoscopist Optical Diagnosis of Diminutive Rectal Polyps When Using the CADDIE System (Intervention Arm) Compared to Without the CADDIE System (Control Arm)
Time frame: 30 days
Evaluate the Safety of the CADDIE by Recording Occurrence and Severity of Adverse Events.
Time frame: 30 days
Assess Patient Anxiety During the Colonoscopy
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Patients will be asked informed consent with the possibility to share the data
Related trials for Polyps
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingObservational study
A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer)
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
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.
Manish Chand, MBBS FRCS PhD principal investigator
UCL
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 Polyps and Adenoma Colon, run by University College, London at 1 site in United Kingdom.
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 3 inclusion and 12 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 19 Feb 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Evaluate Whether Using the CADDIE System Improves Endoscopist Detection of Adenomas During Colonoscopy. (time frame: 30 days). 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 19 Feb 2025.