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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010102
Receipt No. R000011835
Scientific Title Clinical Study of light source (LED) Light-emitting diode illuminated Gastrointestinal Endoscopy
Date of disclosure of the study information 2013/03/01
Last modified on 2020/08/30

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Basic information
Public title Clinical Study of light source (LED) Light-emitting diode illuminated Gastrointestinal Endoscopy
Acronym The efficacy of LED-illuminated endoscope
Scientific Title Clinical Study of light source (LED) Light-emitting diode illuminated Gastrointestinal Endoscopy
Scientific Title:Acronym The efficacy of LED-illuminated endoscope
Region
Japan

Condition
Condition Gastrointestinal disease
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the basic performance and safety of LED illuminated endosope
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of the prototype LED endoscope
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) 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 Endoscopic examination by the prototype endoscope
Interventions/Control_2 Endoscopic examination by commercial endoscope
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Cases require digestive endoscopy for gastrointestinal disease
Key exclusion criteria Consent can not be obtained
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Nishikawa
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 755-8505
Address 1-1-1 Minamikogushi Ube Yamaguchi
TEL 0836-22-2835
Email junnis@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Nishikawa
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 755-8505
Address 1-1-1 Minamikogushi Ube Yamaguchi
TEL 0836-22-2835
Homepage URL
Email junnis@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology
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 Yamaguchi University
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
Tel 0836-22-2111
Email clin_res@yamaguchi-u.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

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2008 Year 09 Month 24 Day
Date of IRB
2008 Year 09 Month 24 Day
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2008 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 23 Day
Last modified on
2020 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011835

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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