Diminutive Colon PolypPhase 4NCT01133041
Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps
A Phase 4 study testing Observation using NBI system and Observation using i-Scan system in people with Diminutive Colon Polyp and Adenomatous Polyp, run by Soon Chun Hyang University at 1 site in South Korea.
Trial summary
Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diminutive Colon Polyp, Adenomatous Polyp, Hyperplastic Polyp
- What is being tested?
- Observation using NBI system and Observation using i-Scan system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Oct 2010
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- screening or surveillance colonoscopy
- age over 18
- informed consent
Who cannot join
- history of inflammatory bowel diseases
- history of hereditary colorectal cancers and polyposis syndrome
- inability to give informed consent
- use of antiplatelet agent and anticoagulants
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soon Chung Hyang University, Cheonan hospital
Cheonan, Choongnam, 330-721
About this study
Official title: Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps
Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).
Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.
Read more
To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.
The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.
In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.
Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.
- Being tested
- Observation using NBI system, Observation using i-Scan system
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation using NBI systemOther
Also called NBI, narrow band imaging (Olympus, Japan)
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Observation using i-Scan systemOther
Also called i-Scan (Pentax, Japan)
I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
| Study group | Role | What they receive |
|---|---|---|
| NBI observation | Experimental | Not described Receives: Other: Observation using NBI system |
| i-Scan observation | Experimental | Not described Receives: Other: Observation using i-Scan system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
Sensitivity, specificity, and diagnostic accuracy
Measured: about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diminutive Colon 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Kyun Lee, Soon Chun Hyang University
- Investigators
- Chang Kyun Lee, MD, PhD, Principal investigator, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133041
- Sponsor's protocol ID
- SCHCH2010L2
- Status last verified
- May 2010
- First submitted
- 27 May 2010
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rastogi A, Pondugula K, Bansal A, Wani S, Keighley J, Sugar J, Callahan P, Sharma P. Recognition of surface mucosal and vascular patterns of colon polyps by using narrow-band imaging: interobserver and intraobserver agreement and prediction of polyp histology. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):716-22. doi: 10.1016/j.gie.2008.09.058.
PubMed 19251016Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
PubMed 19187781Hoffman A, Kagel C, Goetz M, Tresch A, Mudter J, Biesterfeld S, Galle PR, Neurath MF, Kiesslich R. Recognition and characterization of small colonic neoplasia with high-definition colonoscopy using i-Scan is as precise as chromoendoscopy. Dig Liver Dis. 2010 Jan;42(1):45-50. doi: 10.1016/j.dld.2009.04.005. Epub 2009 May 26.
PubMed 19473893Lee CK, Lee SH, Hwangbo Y. Narrow-band imaging versus I-Scan for the real-time histological prediction of diminutive colonic polyps: a prospective comparative study by using the simple unified endoscopic classification. Gastrointest Endosc. 2011 Sep;74(3):603-9. doi: 10.1016/j.gie.2011.04.049. Epub 2011 Jul 18.
PubMed 21762907
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps
- ClinicalTrials.gov ID
- NCT01133041
- Acronym / sponsor ID
- SCHCH2010L2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 May 2010 (estimated)
- 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.
Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).
Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.
To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.
The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.
In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.
Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBI observation | Experimental | Other: Observation using NBI system |
| i-Scan observation | Experimental | Other: Observation using i-Scan system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- screening or surveillance colonoscopy
- age over 18
- informed consent
Key exclusion criteria (5 listed)
- history of inflammatory bowel diseases
- history of hereditary colorectal cancers and polyposis syndrome
- inability to give informed consent
- use of antiplatelet agent and anticoagulants
- pregnancy
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 |
|---|---|---|
| Observation using NBI systemAlso: NBI, narrow band imaging (Olympus, Japan)NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp. | Other | NBI observation |
| Observation using i-Scan systemAlso: i-Scan (Pentax, Japan)I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp. | Other | i-Scan observation |
Primary outcome
Diagnostic efficacy
Time frame: about 1 year
Sensitivity, specificity, and diagnostic accuracy
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 27 Sep 2011.
- Background: PubMed 19251016Rastogi A, Pondugula K, Bansal A, Wani S, Keighley J, Sugar J, Callahan P, Sharma P. Recognition of surface mucosal and vascular patterns of colon polyps by using narrow-band imaging: interobserver and intraobserver agreement and prediction of polyp histology. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):716-22. doi: 10.1016/j.gie.2008.09.058.
- Background: PubMed 19187781Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
- Background: PubMed 19473893Hoffman A, Kagel C, Goetz M, Tresch A, Mudter J, Biesterfeld S, Galle PR, Neurath MF, Kiesslich R. Recognition and characterization of small colonic neoplasia with high-definition colonoscopy using i-Scan is as precise as chromoendoscopy. Dig Liver Dis. 2010 Jan;42(1):45-50. doi: 10.1016/j.dld.2009.04.005. Epub 2009 May 26.
- Derived from this study: PubMed 21762907Lee CK, Lee SH, Hwangbo Y. Narrow-band imaging versus I-Scan for the real-time histological prediction of diminutive colonic polyps: a prospective comparative study by using the simple unified endoscopic classification. Gastrointest Endosc. 2011 Sep;74(3):603-9. doi: 10.1016/j.gie.2011.04.049. Epub 2011 Jul 18.
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.
Chang Kyun Lee, MD, PhD principal investigator
Soon Chun Hyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Observation using NBI system and Observation using i-Scan system in people with Diminutive Colon Polyp and Adenomatous Polyp, run by Soon Chun Hyang University at 1 site in South Korea.
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 3 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 27 Sep 2011. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Diagnostic efficacy (time frame: about 1 year). 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 NCT01133041, which also lists 4 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 27 Sep 2011; AzTrials last refreshed its copy on 28 Oct 2026.