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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022162
Receipt No. 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

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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
Email 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
Email research@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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