Artificial IntelligencePREDICTNCT04589078
Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study
An observational study of Artificial Intelligence, run by Cosmo Artificial Intelligence-AI Ltd at 1 site in Italy.
Trial summary
Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Artificial Intelligence
- What is being tested?
- GI Genius CADe system
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 8 Sep 2020to 22 Dec 2020
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients aged 40-80 undergoing colonoscopy
Who may be able to join
- Patients aged 40-80 undergoing screening colonoscopy for CRC
- Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.
Who cannot join
- subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test;
- subjects undergoing CRC surveillance colonoscopy
- subject at high risk for CRC
- subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic syndromes;
- patients with previous resection of the sigmoid rectum;
- patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings;
- patients who perform an emergency colonoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. As a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). The real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs.
Recently, the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. Two performance standards have been developed to guide the use of advanced imaging:
Read more
- for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps > 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps;
- in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology.
Computer-Aided-Diagnosis (CAD) is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions. The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization.
- Conditions
- Artificial Intelligence
- Being tested
- GI Genius CADe system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Genius CADe systemDevice
Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.
| Study group | Role | What they receive |
|---|---|---|
| Interficial Intelligence | Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available. Receives: Device: GI Genius CADe system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps
Measured: 1 day
Secondary outcomes (1)
Agreement in assignment of post-polypectomy surveillance intervals
Agreement in assignment of post-polypectomy surveillance intervals according to established guidelines between:
- the assignment identified according to the combined
- GI Genius CADx histology prediction for diminutive (≤5 mm) polyps and
- histology for larger polyps (> 5 mm), and
- the assignment identified according to histology only.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start8 Sep 2020
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmo Artificial Intelligence-AI Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589078
- Sponsor's protocol ID
- CB-17-08/05
- Acronym
- PREDICT
- Status last verified
- May 2021
- First submitted
- 13 Oct 2020
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study
- ClinicalTrials.gov ID
- NCT04589078
- Acronym / sponsor ID
- PREDICT / CB-17-08/05
- Conditions
- Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cosmo Artificial Intelligence-AI LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 19 Oct 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.
Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. As a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). The real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs.
Recently, the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. Two performance standards have been developed to guide the use of advanced imaging:
- for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps > 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps;
- in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology.
Computer-Aided-Diagnosis (CAD) is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions. The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interficial Intelligence | – | Device: GI Genius CADe systemEach patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 40-80 undergoing colonoscopy
Key inclusion criteria (2 listed)
- Patients aged 40-80 undergoing screening colonoscopy for CRC
- Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.
Key exclusion criteria (7 listed)
- subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test;
- subjects undergoing CRC surveillance colonoscopy
- subject at high risk for CRC
- subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic syndromes;
- patients with previous resection of the sigmoid rectum;
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 |
|---|---|---|
| GI Genius CADe systemEach patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available. | Device | Interficial Intelligence |
Primary outcome
Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps
Time frame: 1 day
1 secondary outcome
Agreement in assignment of post-polypectomy surveillance intervals
Time frame: 1 day
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 12 May 2021.
- 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.
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?
An observational study of Artificial Intelligence, run by Cosmo Artificial Intelligence-AI Ltd 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 2 inclusion and 7 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 12 May 2021. 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?
Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps (time frame: 1 day). 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 12 May 2021.