UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011965
Receipt number R000013960
Scientific Title Far-Infrared Therapy Treatment will be to Improve Unassisted Patency of Arteriovenous Fistula in Hemodialysis Patients
Date of disclosure of the study information 2013/10/13
Last modified on 2016/12/09 14:31:29

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Basic information

Public title

Far-Infrared Therapy Treatment will be to Improve Unassisted Patency of Arteriovenous Fistula in Hemodialysis Patients

Acronym

Far-Infrared Therapy will be to Improve Unassisted Patency of AVF in HD Patients

Scientific Title

Far-Infrared Therapy Treatment will be to Improve Unassisted Patency of Arteriovenous Fistula in Hemodialysis Patients

Scientific Title:Acronym

Far-Infrared Therapy will be to Improve Unassisted Patency of AVF in HD Patients

Region

Japan


Condition

Condition

hemodialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy of Far-infrared Therapy unassisted patency of arteriovenous fistula in Hemodialysis Patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

secondary patency of AVF

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Far-Infrared Therapy for Patency of Arteriovenous Fistula

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

hemodialysis patients who will be continued for over 12 months

Key exclusion criteria

skin disease patients
blood clotting defect patients

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiko Tomino

Organization

Juntendo University

Division name

Nephrology

Zip code


Address

3-1-1Hongo,Bunkyo-ku,Tokyo

TEL

03-5802-1165

Email

yasu@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Io

Organization

Juntendo University

Division name

Nephrology

Zip code


Address

3-1-1Hongo,Bunkyo-ku,Tokyo

TEL

03-5802-1065

Homepage URL


Email

hiroaki@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

none

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


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



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 13 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

Completed

Date of protocol fixation

2013 Year 09 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 13 Day

Last follow-up date

2015 Year 12 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 10 Month 04 Day

Last modified on

2016 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013960


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name