UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Far-Infrared Therapy Treatment will be to Improve Unassisted Patency of Arteriovenous Fistula in Hemodialysis Patients
Title of the study (Brief title)	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	Yasuhiko Tomino
Organization	Juntendo University
Division name	Nephrology
Address	3-1-1Hongo,Bunkyo-ku,Tokyo
TEL	03-5802-1165
Email	yasu@juntendo.ac.jp

Public contact
Name of contact person	Hiroaki Io
Organization	Juntendo University
Division name	Nephrology
Address	3-1-1Hongo,Bunkyo-ku,Tokyo
TEL	03-5802-1065
Homepage URL
Email	hiroaki@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013960