Polyp of ColonAIFITNCT04691401
Impact of Artificial Intelligence (AI) on Adenoma Detection During Colonoscopy in FIT+ Patients.
A study testing Artificial Intelligence System (CAD EYE, Fujifilm Co.) in people with Polyp of Colon, run by Valduce Hospital at 1 site in Italy.
Trial summary
The Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Polyp of Colon
- What is being tested?
- Artificial Intelligence System (CAD EYE, Fujifilm Co.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2020to 31 Dec 2021
- 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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult (50-74 yrs.) outpatients undergoing colonoscopy in the frame of the FIT-based screening program.
Who cannot join
- patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
- patients with inadequate bowel preparation
- patients in which cecal intubation was not achieved or scheduled for partial examinations
- patients with gastrointestinal symptoms
- polyps could not be resected due to ongoing anticoagulation preventing resection and pathological assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of AI (Artificial Intelligence) on Adenoma Detection During Colonoscopy in FIT+ Patients: a Prospective Randomized Controlled Trial
The Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. Initial studies consistently show that Artificial iIntelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. However, the studies on AI and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. At the best of our knowledge, data on the impact on AI system in adenoma detection in a FIT-based screening program are lacking. The present prospective randomized controlled trial is aimed at evaluating whether the use of an AI system increases the ADR (per patient analysis) and/or the mean number of adenomas per colonoscopy in FIT-positive subjects undergoing screening colonoscopy. Therefore Patients fulfilling the inclusion criteria are randomized (1:1) in two arms: A) patients receive standard colonoscopy (with high definition-HD endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; B) patients receive colonoscopy examinations (with HD endoscopes) equipped with an AI system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. In the present study histopathology represents the reference standard.
- Conditions
- Polyp of Colon
- Being tested
- Artificial Intelligence System (CAD EYE, Fujifilm Co.)
- Keywords
- adenoma detection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence System (CAD EYE, Fujifilm Co.)Device
A dedicated CNN-based AI system (CAD EYE, Fujifilm Co, Tokyo, Japan) has been recently developed. The Computer-aided diagnosis (CAD) CAD EYE system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected.
| Study group | Role | What they receive |
|---|---|---|
| Standard WL (white light) colonoscopy | No intervention | all patients receive standard colonoscopy (with high definition- HD- endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination. |
| Standard colonoscopy with assistance of Artificial Intelligence (CAD-EYE (Fujifilm Co, Tokyo, Japan) | Experimental | all patients receive colonoscopy examinations (with HD endoscopes) equipped with an Ai system (CAD-EYE, Fujifilm Co, Tokyo, Japan) in both insertion and withdrawal phase). This system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected.All polyps identified are removed and sent for histopathology examination. Receives: Device: Artificial Intelligence System (CAD EYE, Fujifilm Co.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADR
Adenoma Detection Rate: rate of participants with at least on adenoma detected during colonoscopy
Measured: 10 months
APC
Adenoma per Colonoscopy: it is determined by dividing the total number of adenomas removed by the total number of colonoscopies performed
Measured: 10 months
Secondary outcomes (2)
Adv-ADR
Adv-ADR: rate of participants with at least on advanced adenoma detected during colonoscopy
Measured: 10 months
SSL-DR:
SSL-ADR: the serrated lesions with neoplastic potential (sessile serrated lesions-SSA; traditional serrated adenomas - TSA) detection rate.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start20 Dec 2020
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp of 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691401
- Sponsor's protocol ID
- 598/2020
- Acronym
- AIFIT
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of AI (Artificial Intelligence) on Adenoma Detection During Colonoscopy in FIT+ Patients: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04691401
- Acronym / sponsor ID
- AIFIT / 598/2020
- Conditions
- Polyp of Colon
- Keywords
- adenoma detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Dec 2020 (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 Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. Initial studies consistently show that Artificial iIntelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. However, the studies on AI and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. At the best of our knowledge, data on the impact on AI system in adenoma detection in a FIT-based screening program are lacking. The present prospective randomized controlled trial is aimed at evaluating whether the use of an AI system increases the ADR (per patient analysis) and/or the mean number of adenomas per colonoscopy in FIT-positive subjects undergoing screening colonoscopy. Therefore Patients fulfilling the inclusion criteria are randomized (1:1) in two arms: A) patients receive standard colonoscopy (with high definition-HD endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; B) patients receive colonoscopy examinations (with HD endoscopes) equipped with an AI system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. In the present study histopathology represents the reference standard.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard WL (white light) colonoscopy | No intervention | –all patients receive standard colonoscopy (with high definition- HD- endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination. |
| Standard colonoscopy with assistance of Artificial Intelligence (CAD-EYE (Fujifilm Co, Tokyo, Japan) | Experimental | Device: Artificial Intelligence System (CAD EYE, Fujifilm Co.)all patients receive colonoscopy examinations (with HD endoscopes) equipped with an Ai system (CAD-EYE, Fujifilm Co, Tokyo, Japan) in both insertion and withdrawal phase). This system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected.All polyps identified are removed and sent for histopathology examination. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive adult (50-74 yrs.) outpatients undergoing colonoscopy in the frame of the FIT-based screening program.
Key exclusion criteria (5 listed)
- patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
- patients with inadequate bowel preparation
- patients in which cecal intubation was not achieved or scheduled for partial examinations
- patients with gastrointestinal symptoms
- polyps could not be resected due to ongoing anticoagulation preventing resection and pathological assessment
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 |
|---|---|---|
| Artificial Intelligence System (CAD EYE, Fujifilm Co.)A dedicated CNN-based AI system (CAD EYE, Fujifilm Co, Tokyo, Japan) has been recently developed. The Computer-aided diagnosis (CAD) CAD EYE system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected. | Device | Standard colonoscopy with assistance of Artificial Intelligence (CAD-EYE (Fujifilm Co, Tokyo, Japan) |
Primary outcome
ADR
Time frame: 10 months
Adenoma Detection Rate: rate of participants with at least on adenoma detected during colonoscopy
APC
Time frame: 10 months
Adenoma per Colonoscopy: it is determined by dividing the total number of adenomas removed by the total number of colonoscopies performed
2 secondary outcomes
Adv-ADR
Time frame: 10 months
SSL-DR:
Time frame: 10 months
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 26 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Polyp of Colon
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence System (CAD EYE, Fujifilm Co.) in people with Polyp of Colon, run by Valduce Hospital at 1 site 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 1 inclusion and 5 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 26 Mar 2024. 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 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?
ADR (time frame: 10 months). 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 26 Mar 2024.