UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025202 |
|---|---|
| Receipt number | R000028990 |
| Scientific Title | The research on establishment of blood flow evaluation method for limb with arterio-venous shunt using OX Imager CS TM. |
| Date of disclosure of the study information | 2016/12/09 |
| Last modified on | 2021/06/13 10:46:02 |
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Basic information
Public title
The research on establishment of blood flow evaluation method for limb with arterio-venous shunt using OX Imager CS TM.
Acronym
A-V shunt limb blood flow evaluation using OX Imager CS TM.
Scientific Title
The research on establishment of blood flow evaluation method for limb with arterio-venous shunt using OX Imager CS TM.
Scientific Title:Acronym
A-V shunt limb blood flow evaluation using OX Imager CS TM.
Region
| Japan |
Condition
Condition
Hemodialysis access induced distal ischemia
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the prompt and non-invasive method for the evaluation of the hemdialysis access induced distal ischemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Wether it is possible to make diagnosis of ischemia by using OX Imager CS TM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Record images using OX Imager CS TM and evaluate the blood flow and analyse the results.
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
1. The patients of hemodialysis induced distal ischemia under care of our division or The patients of hemodialysis induced distal ischemia who will be taken care in future(male and female).
2. The patient who has arteriovenous fistula as a vascular access without access induced distal ischemia.
3. The patients who agreed to participate this study with written informed consent.
Key exclusion criteria
1. The patients determined by the investigator to be unstable as a subject in this study.
2. The patients without written informed consent.
3. The patients less than 20 years old.
4. The patients with dementia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo Medical and Dental University
Division name
Vascular Surgery
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyoku, Tokyo, Japan
TEL
03-3813-5255
yoshi.inoue.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Ichinose |
Organization
Tokyo Medical and Dental University
Division name
Vascular Surgery
Zip code
113-8519
Address
Yushima 1-5-45, Bunkyoku, Tokyo, Japan
TEL
03-5803-5255
Homepage URL
ichinose.srg2@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Vascular Surgery, Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyouku, Tokyo
Tel
03-3813-6111
ichisurg2@tmd.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
東京医科歯科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 09 | 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
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2021 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028990
