Colorectal PolypsNCT07389759
Impact of CADx on Endoscopists' Histologic Characterization of Diminutive Colorectal Polyps
A study testing CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display and CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display in people with Colorectal Polyps, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display and CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2026to 31 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endoscopists with NBI experience
Who cannot join
- -Endoscopists without colonoscopy and NBI experience
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200120
About this study
This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.
Read the detailed description
This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.
In this randomized controlled trial, endoscopists will be assigned to one of three arms: no CADx assistance, CADx assistance without predicted probability, or CADx assistance with predicted probability. The CADx system provides NICE-based histology predictions (Type 1 vs Type 2), which endoscopists may use to support optical diagnosis and subsequent management decisions, including surveillance interval recommendations when applicable. Outcomes will compare endoscopist-level pass rates and diagnostic performance metrics relevant to PIVI-based adoption, with histopathology as the reference standard where applicable.
- Conditions
- Colorectal Polyps
- Being tested
- CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display, CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability DisplayDevice
CADx-assisted optical diagnosis (NBI; predicted probability not displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed without any predicted probability information.
CADx-Assisted Endoscopic Diagnosis System With Predicted Probability DisplayDevice
CADx-assisted optical diagnosis (NBI; predicted probability displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed with accompanying predicted probability information.
| Study group | Role | What they receive |
|---|---|---|
| Standard Colonoscopy (No CADx Assistance) | No intervention | Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) without any CADx assistance. |
| CADx Without Predicted Probability | Experimental | Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions but without any predicted probability information. Receives: Device: CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display |
| CADx With PPredicted Probability | Experimental | Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions and accompanying predicted probability information. Receives: Device: CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pass rate for the "resect and discard" strategy
Proportion of endoscopists who achieve ≥90% accuracy in correctly predicting the patient's recommended surveillance colonoscopy interval according to the 2020 U.S. Multi-Society Task Force (USMSTF) consensus recommendations.
Measured: 14 days
Pass rate for the "diagnose and leave" strategy
Proportion of endoscopists who achieve a negative predictive value (NPV) ≥90% for neoplastic lesions among rectosigmoid polyps, when predictions are made with high diagnostic confidence
Measured: 14 days
Secondary outcomes (7)
Pass rate for the ESGE 2020-based "resect and discard" strategy
The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the ESGE 2020 guideline.
Measured: 14 days
Pass rate for the APWG 2022-based "resect and discard" strategy
The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the APWG 2022 consensus.
Measured: 14 days
Pass rate for the China 2023-based "resect and discard" strategy
The proportion of endoscopists who achieve at least 90% accuracy in correctly predicting the patient's recommended next surveillance colonoscopy interval, using surveillance recommendations based on the Chinese 2023 consensus.
Measured: 14 days
SODA-1 achievement rate
The proportion of endoscopists who, when reporting high diagnostic confidence, meet the SODA-1 performance thresholds for diagnosing neoplastic pathology in diminutive rectosigmoid polyps, as assessed by sensitivity of at least 90% and specificity of at least 80%, with histopathology as the reference standard.
Measured: 14 days
SODA-2 achievement rate
The proportion of endoscopists who, when reporting high diagnostic confidence, meet the SODA-2 performance thresholds for diagnosing neoplastic pathology in diminutive colorectal polyps, as assessed by sensitivity of at least 80% and specificity of at least 80%, with histopathology as the reference standard.
Measured: 14 days
Proportion of high-confidence optical diagnoses
For each endoscopist, the percentage of polyp assessments that are labeled as high diagnostic confidence among all polyp assessments performed.
Measured: 14 days
Accuracy of high-confidence optical diagnosis (neoplastic vs non-neoplastic)
For each endoscopist, the percentage of correct classifications (neoplastic vs non-neoplastic) among assessments labeled as high diagnostic confidence, using histopathology as the reference standard.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start3 Jan 2026
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389759
- Sponsor's protocol ID
- KY2024-080-A-AMD-04
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CADx on Endoscopists' Histologic Characterization of Diminutive Colorectal Polyps
- ClinicalTrials.gov ID
- NCT07389759
- Acronym / sponsor ID
- KY2024-080-A-AMD-04
- Conditions
- Colorectal Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 5 Feb 2026 (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 study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.
Detailed description
This study evaluates the impact of CADx assistance on endoscopists' histologic characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. The primary objective is to determine whether CADx assistance increases the proportion of endoscopists who meet PIVI-related performance thresholds, thereby supporting implementation of the "resect and discard" and "diagnose and leave" strategies in routine clinical practice.
In this randomized controlled trial, endoscopists will be assigned to one of three arms: no CADx assistance, CADx assistance without predicted probability, or CADx assistance with predicted probability. The CADx system provides NICE-based histology predictions (Type 1 vs Type 2), which endoscopists may use to support optical diagnosis and subsequent management decisions, including surveillance interval recommendations when applicable. Outcomes will compare endoscopist-level pass rates and diagnostic performance metrics relevant to PIVI-based adoption, with histopathology as the reference standard where applicable.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Colonoscopy (No CADx Assistance) | No intervention | –Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) without any CADx assistance. |
| CADx Without Predicted Probability | Experimental | Device: CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability DisplayEndoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions but without any predicted probability information. |
| CADx With PPredicted Probability | Experimental | Device: CADx-Assisted Endoscopic Diagnosis System With Predicted Probability DisplayEndoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using NBI, with CADx-displayed NICE classification predictions and accompanying predicted probability information. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopists with NBI experience
Key exclusion criteria (1 listed)
- -Endoscopists without colonoscopy and NBI experience
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 |
|---|---|---|
| CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability DisplayCADx-assisted optical diagnosis (NBI; predicted probability not displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed without any predicted probability information. | Device | CADx Without Predicted Probability |
| CADx-Assisted Endoscopic Diagnosis System With Predicted Probability DisplayCADx-assisted optical diagnosis (NBI; predicted probability displayed). Endoscopists perform optical diagnosis of diminutive colorectal polyps (≤5 mm) during colonoscopy using narrow-band imaging (NBI) with CADx-displayed NICE classification predictions for each polyp. In this arm, the CADx output is displayed with accompanying predicted probability information. | Device | CADx With PPredicted Probability |
Primary outcome
Pass rate for the "resect and discard" strategy
Time frame: 14 days
Proportion of endoscopists who achieve ≥90% accuracy in correctly predicting the patient's recommended surveillance colonoscopy interval according to the 2020 U.S. Multi-Society Task Force (USMSTF) consensus recommendations.
Pass rate for the "diagnose and leave" strategy
Time frame: 14 days
Proportion of endoscopists who achieve a negative predictive value (NPV) ≥90% for neoplastic lesions among rectosigmoid polyps, when predictions are made with high diagnostic confidence
7 secondary outcomes
Pass rate for the ESGE 2020-based "resect and discard" strategy
Time frame: 14 days
Pass rate for the APWG 2022-based "resect and discard" strategy
Time frame: 14 days
Pass rate for the China 2023-based "resect and discard" strategy
Time frame: 14 days
SODA-1 achievement rate
Time frame: 14 days
SODA-2 achievement rate
Time frame: 14 days
Proportion of high-confidence optical diagnoses
Time frame: 14 days
Accuracy of high-confidence optical diagnosis (neoplastic vs non-neoplastic)
Time frame: 14 days
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 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Polyps
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
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal 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 CADx-Assisted Endoscopic Diagnosis System Without Predicted Probability Display and CADx-Assisted Endoscopic Diagnosis System With Predicted Probability Display in people with Colorectal Polyps, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 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 7 Jul 2026. 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 China. 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?
Pass rate for the "resect and discard" strategy (time frame: 14 days). 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 7 Jul 2026.