UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012765 |
|---|---|
| Receipt number | R000014914 |
| Scientific Title | Search for safe and effective operation for renal stones by obserbation using disposable HDIG scope |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2014/01/06 20:36:01 |
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Basic information
Public title
Search for safe and effective operation for renal stones by obserbation using disposable HDIG scope
Acronym
obserbation using disposable HDIG scope
Scientific Title
Search for safe and effective operation for renal stones by obserbation using disposable HDIG scope
Scientific Title:Acronym
obserbation using disposable HDIG scope
Region
| Japan |
Condition
Condition
renal stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness of HDIG scope to apply the scope for operation of renal stone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
safety and effectiveness
Key secondary outcomes
operability
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 with renal stone
Key exclusion criteria
without concent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Kumon |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Urology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7287
kumon@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Wada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Urology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
+81-86-235-7287
Homepage URL
gmd17055@s.okadai.jp
Sponsor or person
Institute
Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Fukushima prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
SUMITA OPTICAL GLASS, Inc.
Takei Medical & Optical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
m14005
Org. issuing International ID_1
Okayama University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
We are planning the results on website of the Department of Urology in Okayama University Hospital after investigation of the study.
Management information
Registered date
| 2014 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014914
