UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012610 |
|---|---|
| Receipt number | R000014746 |
| Scientific Title | bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury |
| Date of disclosure of the study information | 2013/12/31 |
| Last modified on | 2020/06/22 15:45:23 |
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Basic information
Public title
bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Acronym
bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Scientific Title
bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Scientific Title:Acronym
bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Region
| Japan |
Condition
Condition
spinal cord injury
Classification by specialty
| Cardiology | Neurology | Orthopedics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
assessment of postural hypotension in patients with spinal cord injury, and assessment of stabilization of blood pressure by transcutaneous electrical stimulation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
suppression of postural hypotension
Key secondary outcomes
improvement of symptoms
safety
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
transcutaneous electrical stimulation by bionic blood pressure stabilization system
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with spinal cord injury
postural hypotension
Key exclusion criteria
consciousness disturbance patients incapable of agreement
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sunagawa |
Organization
Kyushu University
Division name
Department of cardiovascular medicine
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL
092-642-5359
jsmbe@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Todaka |
Organization
Kyushu University Hospital
Division name
Center for Clinical and Translational Research
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL
092-642-5092
Homepage URL
jsmbe@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Spinal Injuries Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
総合せき損センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2018 | 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
| 2013 | Year | 12 | Month | 17 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014746
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
