UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025779 |
|---|---|
| Receipt number | 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 18:51:49 |
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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
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
sakurama@shigei.or.jp
Sponsor or person
Institute
Shigei Medical Research Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029622
