UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025505 |
|---|---|
| Receipt number | R000029352 |
| Scientific Title | Randomized, Back-to-Back Trial of New Generation of NBI (HQ290) for the Detection of Colorectal Polyps |
| Date of disclosure of the study information | 2017/01/03 |
| Last modified on | 2017/01/03 18:13:16 |
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Basic information
Public title
Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Acronym
Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Scientific Title
Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Scientific Title:Acronym
Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Region
| Asia(except Japan) |
Condition
Condition
Colon polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare polyp miss rates of the 290-NBI colonoscopy with high-definition white light with wide angle (CF-HQ 290) colonoscopy in patients undergoing colonoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Polyp and adenoma miss rates
Key secondary outcomes
Polyp and adenoma detection rates
Factors associated with polyp miss rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We used NBI-290 during colonoscopy.
Interventions/Control_2
We used wide angle white light colonoscopy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients undergoing colonoscopy
1) Diagnostic work up
2) Surveillance of colorectal polyps
3) Colorectal cancer screening
Key exclusion criteria
Famillial colorectal cancer syndrome (FAP or HNP)
Personal history of colorectal cancer or inflammatory bowel disease
Previous colonic resection
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Bong Min Ko |
Organization
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea
Division name
Digestive Disease Center and Research Institute
Zip code
Address
SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL
+82-32-621-5094
koppa9445@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyeon Jeong Goong |
Organization
Department of Internal Medicine, SoonChunHyang University
Division name
Digestive Disease Center and Research Institute
Zip code
Address
SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL
+82-32-621-5094
Homepage URL
goong@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University, school of medicine
Institute
Department
Personal name
Funding Source
Organization
There is no funding source.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 03 | Day |
Last modified on
| 2017 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029352
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
