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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name