Colonic PolypCHANGENCT04884581
Characterization of Colorectal Neoplasia
A study testing GI Genius CADx device in people with Colonic Polyp, run by Nuovo Regina Margherita Hospital at 1 site in Italy.
Trial summary
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- GI Genius CADx device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2021to 5 Aug 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 years or older 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 at high risk for colorectal cancer
- subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis 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
Official title: The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
- Conditions
- Colonic Polyp
- Being tested
- GI Genius CADx device
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Genius CADx deviceDevice
GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma.
| Study group | Role | What they receive |
|---|---|---|
| GI Genius CADx device | Experimental | Not described Receives: Device: GI Genius CADx device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value (NPV)
Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start12 May 2021
- Primary completion1 Jul 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuovo Regina Margherita Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesare Hassan, Nuovo Regina Margherita Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884581
- Sponsor's protocol ID
- CHANGE Study
- Acronym
- CHANGE
- Status last verified
- Aug 2021
- First submitted
- 7 May 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brenner TA, Labaki C, Feuerstein JD, Berzin TM. Prospective Validation of the First US FDA-Approved Computer-Aided Quality Assessment Tool for Colonoscopy: An Initial Clinical Experience. Am J Gastroenterol. 2026 Apr 1;121(4):1036-1040. doi: 10.14309/ajg.0000000000003855. Epub 2025 Nov 19.
PubMed 41257531Hassan C, Balsamo G, Lorenzetti R, Zullo A, Antonelli G. Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2505-2513.e4. doi: 10.1016/j.cgh.2022.04.045. Epub 2022 Jul 11.
PubMed 35835342
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT04884581
- Acronym / sponsor ID
- CHANGE / CHANGE Study
- Conditions
- Colonic Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Nuovo Regina Margherita HospitalUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 13 May 2021 (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.
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GI Genius CADx device | Experimental | Device: GI Genius CADx device |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 40 years or older undergoing screening colonoscopy for CRC
- Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation
Key exclusion criteria (5 listed)
- subjects at high risk for colorectal cancer
- subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis 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
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 CADx deviceGI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma. | Device | GI Genius CADx device |
Primary outcome
Negative Predictive Value (NPV)
Time frame: 4 months
Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps
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 6 Aug 2021.
- Derived from this study: PubMed 41257531Brenner TA, Labaki C, Feuerstein JD, Berzin TM. Prospective Validation of the First US FDA-Approved Computer-Aided Quality Assessment Tool for Colonoscopy: An Initial Clinical Experience. Am J Gastroenterol. 2026 Apr 1;121(4):1036-1040. doi: 10.14309/ajg.0000000000003855. Epub 2025 Nov 19.
- Derived from this study: PubMed 35835342Hassan C, Balsamo G, Lorenzetti R, Zullo A, Antonelli G. Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2505-2513.e4. doi: 10.1016/j.cgh.2022.04.045. Epub 2022 Jul 11.
- 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?
A study testing GI Genius CADx device in people with Colonic Polyp, run by Nuovo Regina Margherita 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 2 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 6 Aug 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 (NPV) (time frame: 4 months). 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 NCT04884581, which also lists 2 linked publications.
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 6 Aug 2021.