UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026178 |
|---|---|
| Receipt number | R000029999 |
| Scientific Title | Evaluation of air shock pants for orthostatic hypotension treatment |
| Date of disclosure of the study information | 2017/02/16 |
| Last modified on | 2017/02/16 20:41:08 |
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Basic information
Public title
Evaluation of air shock pants for orthostatic hypotension treatment
Acronym
Evaluation of air shock pants for orthostatic hypotension treatment
Scientific Title
Evaluation of air shock pants for orthostatic hypotension treatment
Scientific Title:Acronym
Evaluation of air shock pants for orthostatic hypotension treatment
Region
| Japan |
Condition
Condition
Orthostatic hypotension
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of newly developed air shock-pants controlled automatically by blood pressure for patients with orthostatic hypotension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The device can restore the decreased blood pressure and prevent symptoms of syncope in standing or sitting.
Key secondary outcomes
1) Patients can wear it comfortably without inhibiting breathing.
2) The device does not cause malfunction for a blood pressure drop.
3) Change of catecholamine
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To evaluate whether the device could restore blood pressure lowering and prevent symptoms of syncope by standing or sitting.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with orthostatic hypotension due to baroreflex failure (e.g. autonomic disorder with Parkinson disease or Shy-Drager syndrome, spinal code injury or abdominal surgery).
Key exclusion criteria
Patients with deep vein thrombosis by echographic examination
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiyasu Yamasaki |
Organization
Kochi Medical School
Division name
Clinical Laboratory
Zip code
Address
Nankoku, Kochi, 783-8505, Japan
TEL
088-866-5811
yamasakf-kochimed@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiyasu Yamasaki |
Organization
Kochi Medical School
Division name
Clinical Laboratory
Zip code
Address
Nankoku, Kochi, 783-8505, Japan
TEL
088-866-5811
Homepage URL
yamasakf-kochimed@umin.net
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
1)Japan Science and Technology Agency
2)Japan Society for the Promotion of Science
3)Tokyo Aircraft Instrument Co.,Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1)Tokyo Aircraft Instrument Co.,Ltd.
2)The Fujikura Parachute Co.,Ltd.
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
高知大学医学部付属病院(高知県)
いずみの病院(高知県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 16 | 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
Date of protocol fixation
| 2014 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2017 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029999
