UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010102 |
|---|---|
| Receipt number | 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 12:27:13 |
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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
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
junnis@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011835
