UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030631 |
|---|---|
| Receipt number | R000034976 |
| Scientific Title | Safety study to evaluate the usefulness of optimal needle guide(ONG) under ultrasound-guided CVC |
| Date of disclosure of the study information | 2017/12/29 |
| Last modified on | 2024/05/07 09:36:55 |
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Basic information
Public title
Safety study to evaluate the usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Acronym
Usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Scientific Title
Safety study to evaluate the usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Scientific Title:Acronym
Usefulness of optimal needle guide(ONG) under ultrasound-guided CVC
Region
| Japan |
Condition
Condition
candidate for CVC insertion
Classification by specialty
| Operative medicine | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safely whether the medical doctors who received training program can perform the puncture by ultrasound-guided ONG.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The incidence of multiple puncture
Key secondary outcomes
The incidence of complications by the puncture
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After the CVC puncture using ultrasound-guided ONG is successful, this intervension will be finished.
The two time of CVC puncture is allowed.
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
1)
more than 20 years old
2)
candidate for CVC insertion
Key exclusion criteria
1)
seriously deteriorated general condition
2)
patients with high fever of moe than 38
degrees
3)
patients with operated scar or infection
in the lesion of puncture
4)
not appropriate for the registration of
this study according to physician's
judgement
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Hospital
Division name
Innovative medical Research Center
Zip code
Address
3-39-15, showa-machi, maebashi, Gunma, Japan
TEL
027-220-8347
kkaira1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Hospital
Division name
Innovative medical Research Center
Zip code
Address
3-39-15, showa-machi, maebashi, Gunma, Japan
TEL
027-220-8347
Homepage URL
http://imrc.med.gunma-u.ac.jp/
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 12 | Month | 29 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034976
