UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024615 |
|---|---|
| Receipt number | 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 12:25:51 |
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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
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
kobapi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027635
