UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058859 |
|---|---|
| Receipt number | R000067312 |
| Scientific Title | Multicenter prospECtive observational study: lesion morpHOlogy in sonogram and efficacy of drug-coated balloon for dysfunctional arteriovenous fistulas |
| Date of disclosure of the study information | 2025/09/04 |
| Last modified on | 2025/08/21 21:25:29 |
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Basic information
Public title
Multicenter prospective observational study:lesion characteristic in sonogram and efficacy of drug-coated balloon for dysfunctional arteriovenous fistulas
Acronym
ECHO DCB study
Scientific Title
Multicenter prospECtive observational study: lesion morpHOlogy in sonogram and efficacy of drug-coated balloon for dysfunctional arteriovenous fistulas
Scientific Title:Acronym
ECHO DCB study
Region
| Japan |
Condition
Condition
dysfunctional arteriovenous fistulas
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reveal the relationship between lesion morphology in sonogram and efficacy of drug-coated balloon for dysfunctional arteriovenous fistulas
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
access circuit primary patency
Key secondary outcomes
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
20 years-old<=
Key exclusion criteria
Not eligible for the definition of access circuit
Not eligible for the entry to this study in some conditons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamawaki |
Organization
Mie university hospital
Division name
Nephrology
Zip code
514-8507
Address
2-174,Edobashi, Tsu city, Mie 514-8507 JAPAN
TEL
059-232-1111
m-yamawaki@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamawaki |
Organization
Mie university hospital
Division name
Nephrology
Zip code
514-8507
Address
2-174,Edobashi, Tsu city, Mie 514-8507 JAPAN
TEL
059-232-1111
Homepage URL
m-yamawaki@med.mie-u.ac.jp
Sponsor or person
Institute
Mie university hospital
Institute
Department
Personal name
Masahiro Yamawaki
Funding Source
Organization
Department of Cardiology and Nephrology, Mie University Graduate school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174,Edobashi, Tsu city, Mie 514-8507 JAPAN
Tel
059-231-5045
kk-sien@med.mie-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
三重大学医学部附属病院(三重県)、亀山透析クリニック(三重県)、桑名市総合医療センター(三重県)、武内病院(三重県)、津みなみクリニック(三重県)、名張市立病院(三重県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 04 | 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
| 2025 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Reveal the relationship between lesion morphology in sonogram and efficacy of drug-coated balloon for dysfunctional arteriovenous fistulas
Management information
Registered date
| 2025 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067312
