UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022162 |
|---|---|
| Receipt number | R000025520 |
| Scientific Title | Randomised cross-over comparative study of FUSE colonoscopy |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2019/05/05 11:58:57 |
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Basic information
Public title
Randomised cross-over comparative study of FUSE colonoscopy
Acronym
Randomised cross-over comparative study of FUSE colonoscopy
Scientific Title
Randomised cross-over comparative study of FUSE colonoscopy
Scientific Title:Acronym
Randomised cross-over comparative study of FUSE colonoscopy
Region
| Japan |
Condition
Condition
Established or suspected colorectal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Current colonoscopy uses only the front view, the angle of which is 170 degrees. EndoChoice has launched Full Spectrum Endoscopy(FUSE). FUSE colonoscopy has both side views in addition to the front view (in total 330 degrees). In this study, we compare the detection rates of colorectal disease between 3 views and a single view at FUSE colonoscopy by randomized cross-over study stratified by endoscopic experience.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Detection rates of colorectal diseases
Key secondary outcomes
1.Examination time
2.Changes in vital signs
3.Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Triple view or single view
Interventions/Control_2
Experience of 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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with established or suspicious colorectal diseases
Key exclusion criteria
1. Patients with complications such as perforation.
2. Patients inappropriate for this study by other reasons judged by investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Gastroenterology
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562939240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Ikue |
| Middle name | |
| Last name | Tanigawa |
Organization
Fujita Health University School of Medicine
Division name
IRB
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562932860
Homepage URL
research@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
IRB
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2139
research@fujita-hu.ac.jp
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
藤田保健衛生大学第一病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 02 | 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
70
Results
We enrolled 70 participants (53 men, 17 women) between July 2016 and November 2017, and randomly allocated them to a FV-first group or a FUSE-first group according to age, sex, and colonoscopic experience.
Results date posted
| 2019 | Year | 05 | Month | 05 | Day |
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
| 2015 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025520
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