UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045440 |
|---|---|
| Receipt number | R000051805 |
| Scientific Title | Detection of Blood Flow Speed on Hemodialysis Patient Using Diffuse Correlation Spectroscopy |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2024/04/11 15:15:36 |
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Basic information
Public title
Detection of Blood Flow Speed on Hemodialysis Patient Using Diffuse Correlation Spectroscopy
Acronym
Detection of Blood Flow Speed on Hemodialysis Patient Using Diffuse Correlation Spectroscopy
Scientific Title
Detection of Blood Flow Speed on Hemodialysis Patient Using Diffuse Correlation Spectroscopy
Scientific Title:Acronym
Detection of Blood Flow Speed on Hemodialysis Patient Using Diffuse Correlation Spectroscopy
Region
| Japan |
Condition
Condition
Hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We propose a novel application of diffuse correlation spectroscopy to evaluate microvascular malfunctions of muscle tissue on hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate microvascular of muscle tissue on hemodialysis patients.
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemodialysis Patients
Key exclusion criteria
Patients who cannot keep at rest on hemodialysis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Kojima |
Organization
St.Marianna University School of Medicine
Division name
Division of Nephrology and Hypertension
Zip code
216-8511
Address
2-16-1 Sugau Miyamae-ku Kawasaki-city Kanagawa-prefecture Japan
TEL
044-977-8111
suguru.takayama@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Takayama |
Organization
St.Marianna University School of Medicine
Division name
Division of Nephrology and Hypertension
Zip code
216-8511
Address
2-16-1 Sugau Miyamae-ku Kawasaki-city Kanagawa-prefecture Japan
TEL
044-977-8111
Homepage URL
suguru.takayama@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University 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
St.Marianna University School of Medicine
Address
2-16-1 Sugau Miyamae-ku Kawasaki-city Kanagawa-prefecture Japan
Tel
044-977-8111
suguru.takayama@marianna-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
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 10 | 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
out break of covid-19 infection
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051805
