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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024615
Receipt No. R000027635
Scientific Title A study to compare the diagnostic accurasy of Blue LASER Imaging or Linked Color Imaging using LED light source and LASER light source in a neoplastic lesion of esophagus.
Date of disclosure of the study information 2016/11/01
Last modified on 2019/05/02

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Basic information
Public title A study to compare the diagnostic accurasy of Blue LASER Imaging or Linked Color Imaging using LED light source and LASER light source in a neoplastic lesion of esophagus.
Acronym A study to compare the diagnostic accurasy of Blue LASER Imaging or Linked Color Imaging in a neoplastic lesion of esophagus.
Scientific Title A study to compare the diagnostic accurasy of Blue LASER Imaging or Linked Color Imaging using LED light source and LASER light source in a neoplastic lesion of esophagus.
Scientific Title:Acronym A study to compare the diagnostic accurasy of Blue LASER Imaging or Linked Color Imaging in a neoplastic lesion of esophagus.
Region
Japan

Condition
Condition superficial esophageal cancer,esophageal dysplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to clarify the usefullness of Blue LASER Imaging using LED light source
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to compare the diagnostic accuracy of Blue LASER Imaging using LED light source and LASER light source
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 LED light source group
Interventions/Control_2 LASER light source group
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 who have a therapy for esophageal cancer or dysplasia
Key exclusion criteria Patients whom a researcher judged to be inappropriate as a subject
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Hirooka
Organization Nagoya University Graduate School of Medicine
Division name Department of Endoscopy
Zip code 466-8560
Address 65, Tsuruma-cho Showa-ku, Nagoya, 466-8550 Japan.
TEL 052-744-2431
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kobayashi
Middle name
Last name Kenichi
Organization Nagoya University Graduate School of Medicine
Division name Department of Endoscopy
Zip code 466-8560
Address 65, Tsuruma-cho Showa-ku, Nagoya, 466-8550 Japan.
TEL 052-744-2431
Homepage URL
Email kobapi@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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 life ethics committee
Address 65, Tsuruma-cho Showa-ku, Nagoya, 466-8550 Japan.
Tel 0527442423
Email ethics@med.nagoya-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
2016 Year 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
2016 Year 11 Month 21 Day
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 28 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027635

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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