UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and Efficacy of medical support device for tunneled cuffed catheter in hemodialysis patients
Title of the study (Brief title)	Safety and Efficacy of medical support device for tunneled cuffed catheter in hemodialysis patients
Region	Japan

Condition
Condition	Chronic renal failure
Classification by specialty	Nephrology Surgery in general Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There is no suitable device to support the accurate placement of tunneled cuffed catheter. The purpose of this study is to evaluate the safety and efficacy of our developed new device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety Success rate of accurate insetion (Placement accuracy was determined by measuring the distance and gap in the computed tomography before and after catheterzation.)
Key secondary outcomes	Function of shunt in 2 months

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	New device was used for all patients adapted for tunneled cuffed catheter.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Hemodialysis patients adaped for tunneled cuffed catheter
Key exclusion criteria	Patietns who cannot communicate Patients who are judged to be inappopriate by doctor
Target sample size	10

Research contact person
Name of lead principal investigator	Sakurama Kazufumi
Organization	Shigei Medical Research Hospital
Division name	Surgery
Address	2117 Yamada, Minami-ku, Okayama, Japan
TEL	086(282)5311
Email	sakurama@shigei.or.jp

Public contact
Name of contact person	Sakurama Kazufumi
Organization	Shigei Medical Research Hospital
Division name	Surgery
Address	2117 Yamada, Minami-ku, Okayama, Japan
TEL	086(282)5311
Homepage URL
Email	sakurama@shigei.or.jp

Sponsor
Institute	Shigei Medical Research Hospital
Institute
Department

Funding Source
Organization	Shigei Medical Research Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 12 Day
Anticipated trial start date	2016 Year 01 Month 18 Day
Last follow-up date	2016 Year 12 Month 23 Day
Date of closure to data entry	2016 Year 12 Month 23 Day
Date trial data considered complete	2016 Year 12 Month 23 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2017 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029622