Colorectal PolypsNCT06922877
Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps
A study testing Optical diagnosis based on JNET classification with WASP features (no 3D assistance) and Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance in people with Colorectal Polyps and Colorectal Adenomas, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
This study investigated whether adding a three-dimensional (3D) imaging view during colonoscopy helps doctors classify small colon polyps more accurately than standard colonoscopy without 3D. Polyps are small growths in the colon that may develop into cancer over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyps, Colorectal Adenomas
- What is being tested?
- Optical diagnosis based on JNET classification with WASP features (no 3D assistance) and Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years;
- Underwent non-3D white-light colonoscopy with at least one colorectal polyp identified;
- Endoscopically estimated polyp size <10 mm;
- No indication for endoscopic submucosal dissection (ESD);
- Scheduled for inpatient polypectomy;
- Provided written informed consent.
Who cannot join
- History of any polypectomy;
- History of colorectal surgery;
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis);
- Hereditary polyposis syndromes;
- Concurrent colorectal cancer;
- Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency);
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- Coagulopathy or failure to discontinue antithrombotic agents;
- Inability to cooperate with procedures;
- Pregnancy or lactation;
- Refusal to participate or inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps: A Prospective Randomized Controlled Trial
This study investigated whether adding a three-dimensional (3D) imaging view during colonoscopy helps doctors classify small colon polyps more accurately than standard colonoscopy without 3D. Polyps are small growths in the colon that may develop into cancer over time. When doctors remove polyps, they often examine them closely during the procedure to judge how likely they are to be precancerous-a process called optical diagnosis.
In this study, two approaches to optical diagnosis were compared: diagnosis using standard colonoscopy without 3D, and diagnosis using the same colonoscopy with additional 3D imaging. Both groups used the same classification systems (JNET and WASP) to identify polyp type; the only difference was whether 3D imaging was used. The main question was whether adding 3D improves the agreement between the doctor's diagnosis during colonoscopy and the final laboratory diagnosis of the removed polyp. The study also collected safety information.
Participants were randomly assigned to one of the two groups, like flipping a coin. Regardless of group, all participants underwent an initial colonoscopy to detect polyps, a second colonoscopy to remove polyps and perform optical diagnosis, and a follow-up period of up to 30 days to monitor for side effects. The study included adults with at least one colon polyp smaller than 10 mm that did not require a more advanced type of removal called ESD.
- Conditions
- Colorectal Polyps, Colorectal Adenomas
- Being tested
- Optical diagnosis based on JNET classification with WASP features (no 3D assistance), Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance
- Keywords
- three dimension imaging device, colorectal polyps, colorectal adenomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical diagnosis based on JNET classification with WASP features (no 3D assistance)Diagnostic test
Real-time optical diagnosis of colorectal polyps <10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy without 3D assistance.
Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistanceDiagnostic test
Real-time optical diagnosis of colorectal polyps <10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy with 3D imaging assistance.
| Study group | Role | What they receive |
|---|---|---|
| non-3D group | Active comparator | Participants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, without 3D assistance. Receives: Diagnostic Test: Optical diagnosis based on JNET classification with WASP features (no 3D assistance) |
| 3D imaging arm | Experimental | Participants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy with additional 3D imaging assistance. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, integrating 3D visualization. Receives: Diagnostic Test: Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall diagnostic concordance of endoscopic polyp classification
The overall proportion of correct classifications by endoscopy (3D vs. non-3D) compared to the gold standard (pathology) at the lesion level, across all polyp types.
Measured: 1-7 days after polypectomy
Secondary outcomes (5)
Diagnostic confidence
The proportion of lesions classified with high versus low diagnostic confidence by the endoscopist during real-time optical diagnosis. High confidence was defined as clear visualization of both vascular and surface patterns permitting a definitive JNET classification; low confidence was defined as suboptimal visualization or ambiguous features precluding a definitive classification.
Measured: During the endoscopic procedure, immediately after optical diagnosis
Diagnostic concordance for adenomas and sessile serrated lesions (SSLs)
The overall proportion of correct classifications by endoscopy compared with the gold standard (pathology) at the lesion level for adenomas and for sessile serrated lesions, respectively.
Measured: 1-7 days after polypectomy
Diagnostic concordance for identifying patients requiring surveillance
The proportion of patients for whom the surveillance interval assigned by optical diagnosis matches the interval assigned by pathology, according to the 2020 ESGE guideline. Surveillance intervals were determined based on all resected polyps, including those >10 mm, reflecting real-world clinical practice.
Measured: 1-7 days after polypectomy
Diagnostic characteristics (sensitivity, specificity, PPV, NPV) for adenomas and SSLs
Diagnostic performance measures for endoscopic classification (3D vs. non-3D) in detecting adenomas and sessile serrated lesions at the lesion level, using final pathology as the gold standard. Measures include sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).
Measured: 1-7 days after polypectomy
The colonoscopy-relevant adverse events
aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy
Measured: 1-30 days after polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 May 2025
- Primary completion31 Mar 2026
- Study completion30 Apr 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.
- 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
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Zhiguo Liu, M.D, Principal investigator, Xijing Hospital of Digestive DIsease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922877
- Sponsor's protocol ID
- KY20242178-F-1
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared. The study protocol and statistical analysis plan will also be made available. Data will be available beginning 6 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving the aims in the approved proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06922877
- Acronym / sponsor ID
- KY20242178-F-1
- Conditions
- Colorectal Polyps, Colorectal Adenomas
- Keywords
- three dimension imaging device, colorectal polyps, colorectal adenomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 Apr 2025 (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 investigated whether adding a three-dimensional (3D) imaging view during colonoscopy helps doctors classify small colon polyps more accurately than standard colonoscopy without 3D. Polyps are small growths in the colon that may develop into cancer over time. When doctors remove polyps, they often examine them closely during the procedure to judge how likely they are to be precancerous-a process called optical diagnosis.
In this study, two approaches to optical diagnosis were compared: diagnosis using standard colonoscopy without 3D, and diagnosis using the same colonoscopy with additional 3D imaging. Both groups used the same classification systems (JNET and WASP) to identify polyp type; the only difference was whether 3D imaging was used. The main question was whether adding 3D improves the agreement between the doctor's diagnosis during colonoscopy and the final laboratory diagnosis of the removed polyp. The study also collected safety information.
Participants were randomly assigned to one of the two groups, like flipping a coin. Regardless of group, all participants underwent an initial colonoscopy to detect polyps, a second colonoscopy to remove polyps and perform optical diagnosis, and a follow-up period of up to 30 days to monitor for side effects. The study included adults with at least one colon polyp smaller than 10 mm that did not require a more advanced type of removal called ESD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-3D group | Active comparator | Diagnostic Test: Optical diagnosis based on JNET classification with WASP features (no 3D assistance)Participants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, without 3D assistance. |
| 3D imaging arm | Experimental | Diagnostic Test: Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistanceParticipants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy with additional 3D imaging assistance. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, integrating 3D visualization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥18 years;
- Underwent non-3D white-light colonoscopy with at least one colorectal polyp identified;
- Endoscopically estimated polyp size <10 mm;
- No indication for endoscopic submucosal dissection (ESD);
- Scheduled for inpatient polypectomy;
Key exclusion criteria (10 listed)
- History of any polypectomy;
- History of colorectal surgery;
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis);
- Hereditary polyposis syndromes;
- Concurrent colorectal cancer;
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 |
|---|---|---|
| Optical diagnosis based on JNET classification with WASP features (no 3D assistance)Real-time optical diagnosis of colorectal polyps <10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy without 3D assistance. | Diagnostic test | non-3D group |
| Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistanceReal-time optical diagnosis of colorectal polyps <10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy with 3D imaging assistance. | Diagnostic test | 3D imaging arm |
Primary outcome
Overall diagnostic concordance of endoscopic polyp classification
Time frame: 1-7 days after polypectomy
The overall proportion of correct classifications by endoscopy (3D vs. non-3D) compared to the gold standard (pathology) at the lesion level, across all polyp types.
5 secondary outcomes
Diagnostic confidence
Time frame: During the endoscopic procedure, immediately after optical diagnosis
Diagnostic concordance for adenomas and sessile serrated lesions (SSLs)
Time frame: 1-7 days after polypectomy
Diagnostic concordance for identifying patients requiring surveillance
Time frame: 1-7 days after polypectomy
Diagnostic characteristics (sensitivity, specificity, PPV, NPV) for adenomas and SSLs
Time frame: 1-7 days after polypectomy
The colonoscopy-relevant adverse events
Time frame: 1-30 days after polypectomy
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared. The study protocol and statistical analysis plan will also be made available. Data will be available beginning 6 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving the aims in the approved proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
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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.
Zhiguo Liu, M.D principal investigator
Xijing Hospital of Digestive DIsease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical diagnosis based on JNET classification with WASP features (no 3D assistance) and Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance in people with Colorectal Polyps and Colorectal Adenomas, run by Xijing Hospital of Digestive Diseases 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 6 inclusion and 10 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 10 Sep 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?
Overall diagnostic concordance of endoscopic polyp classification (time frame: 1-7 days after polypectomy). 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 10 Sep 2026.