Intestinal PolypsNCT01577875
Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy
A study testing NBI with magnification in people with Intestinal Polyps, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Polyps
- What is being tested?
- NBI with magnification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Mar 2013
- 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
- Subjects with colorectal polyps which are in need of EMR
Who cannot join
- pregnancy, IBD, colorectal cancer, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps
The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.
Read the detailed description
The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.
- Conditions
- Intestinal Polyps
- Being tested
- NBI with magnification
- Medical subject headings
- Intestinal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI with magnificationDevice
Also called Narrow band image with magnification
After randomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. Two groups will be compared with each other.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | histologic prediction only with the narrow band imaging (without magnification) |
| test group | Other | histologic prediction with narrow band imaging plus magnification Receives: Device: NBI with magnification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
After radomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. After 1 week, confirmed pathologic diagnosis and predicted histologic diagnosis based on endoscopic observation are compared and its accuracy is evaluated.
Measured: After 1 week
Secondary outcomes (4)
Sensitivity of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of sensitivity.
Measured: 1 Week
Specificity of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of specificity.
Measured: 1 Week
Positive predictive value of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of positive predictive value.
Measured: 1 Week
Negative predictive value of the endoscopic histologic prediction with NBI plus magnification
Endoscopically predicted histologic diagnosis compared with confirmed pathologic diagnosis are evaluated in terms of negative predictive value.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal PolypsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyoung Sup Hong, MD, Principal investigator, SNUH Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577875
- Sponsor's protocol ID
- NBI_Zoom_CVS_01
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Evaluate Narrow Band Imaging and Magnifying Colonoscopy for the Histologic Prediction of Colorectal Polyps
- ClinicalTrials.gov ID
- NCT01577875
- Acronym / sponsor ID
- NBI_Zoom_CVS_01
- Conditions
- Intestinal Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Apr 2012 (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.
The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.
Detailed description
The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –histologic prediction only with the narrow band imaging (without magnification) |
| test group | Other | Device: NBI with magnificationhistologic prediction with narrow band imaging plus magnification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with colorectal polyps which are in need of EMR
Key exclusion criteria (1 listed)
- pregnancy, IBD, colorectal cancer, etc.
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 |
|---|---|---|
| NBI with magnificationAlso: Narrow band image with magnificationAfter randomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. Two groups will be compared with each other. | Device | test group |
Primary outcome
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification
Time frame: After 1 week
After radomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. After 1 week, confirmed pathologic diagnosis and predicted histologic diagnosis based on endoscopic observation are compared and its accuracy is evaluated.
4 secondary outcomes
Sensitivity of the endoscopic histologic prediction with NBI plus magnification
Time frame: 1 Week
Specificity of the endoscopic histologic prediction with NBI plus magnification
Time frame: 1 Week
Positive predictive value of the endoscopic histologic prediction with NBI plus magnification
Time frame: 1 Week
Negative predictive value of the endoscopic histologic prediction with NBI plus magnification
Time frame: 1 Week
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 20 Nov 2014.
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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.
Kyoung Sup Hong, MD principal investigator
SNUH Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBI with magnification in people with Intestinal Polyps, run by Seoul National University Hospital 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 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 20 Nov 2014. 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.
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?
Accuracy of colorectal polyp histologic prediction with NBI colonoscopy plus magnification (time frame: After 1 week). 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 20 Nov 2014.