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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025779
Receipt No. R000029622
Scientific Title Safety and Efficacy of medical support device for tunneled cuffed catheter in hemodialysis patients
Date of disclosure of the study information 2017/01/20
Last modified on 2017/02/18

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Basic information
Public title Safety and Efficacy of medical support device for tunneled cuffed catheter in hemodialysis patients
Acronym Safety and Efficacy of medical support device for tunneled cuffed catheter in hemodialysis patients
Scientific Title Safety and Efficacy of medical support device for tunneled cuffed catheter in hemodialysis patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Sakurama Kazufumi
Organization Shigei Medical Research Hospital
Division name Surgery
Zip code
Address 2117 Yamada, Minami-ku, Okayama, Japan
TEL 086(282)5311
Email sakurama@shigei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakurama Kazufumi
Organization Shigei Medical Research Hospital
Division name Surgery
Zip code
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)

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
2017 Year 01 Month 20 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
2016 Year 01 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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