UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028595 |
|---|---|
| Receipt number | R000032731 |
| Scientific Title | NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2018/08/10 14:28:58 |
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Basic information
Public title
NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection
Acronym
NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection
Scientific Title
NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection
Scientific Title:Acronym
NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate colrectal polyp detection rate due to Endocuff-assisted colonoscopy in NBI or WLE
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
colorectal polyp detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are 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
NBI colonoscopy with the use of Endocuff
Interventions/Control_2
white light colonoscopy with the use of Endocuff
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing colonoscopy
Key exclusion criteria
previous bowel resection, inflammatory bowel disease and polyposis syndromes
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Wada |
Organization
Wada Clinic
Division name
Endoscopic department
Zip code
Address
1-4-21, Oda, Wakayama
TEL
073-473-5252
w-yoshi@mtj.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Wada |
Organization
Wada Clinic
Division name
Endoscopic department
Zip code
Address
1-4-21, Oda, Wakayama
TEL
073-473-5252
Homepage URL
w-yoshi@mtj.biglobe.ne.jp
Sponsor or person
Institute
Wada Clinic
Institute
Department
Personal name
Funding Source
Organization
Wada Clinic
Organization
Division
Category of Funding Organization
Self funding
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 | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032731
