UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056878 |
|---|---|
| Receipt number | R000065002 |
| Scientific Title | Evaluation of the Effectiveness and Safety of an Upper Arm Evaluation of the Effectiveness and Safety of an Upper Arm Fixation |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2026/01/09 15:10:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Effectiveness and Safety of an Upper Arm Evaluation of the Effectiveness and Safety of an Upper Arm Fixation
Acronym
valuation of the Effectiveness and Safety of an Upper Arm Evaluation of the Effectiveness and Safety of an Arm Fixation
Scientific Title
Evaluation of the Effectiveness and Safety of an Upper Arm Evaluation of the Effectiveness and Safety of an Upper Arm Fixation
Scientific Title:Acronym
valuation of the Effectiveness and Safety of an Upper Arm Evaluation of the Effectiveness and Safety of an Arm Fixation
Region
| Japan |
Condition
Condition
Diseases Requiring Cardiac Catheterization
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study was to assess the effectiveness and safety of a proprietary fixation device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree and frequency of device misalignment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Create device
Interventions/Control_2
nomal device
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
Persons with written consent.
Key exclusion criteria
1. people with neurological and motor impairments
2. people who are unable to communicate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Mano |
Organization
Fujita Health University Hospital
Division name
Nursing Department
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2111
hp1.nurse@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Watanabe |
Organization
FUJITA HEALTH UNIVERSITY
Division name
Center for Collaboration in Research and Innovation
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2000
Homepage URL
fuji-san@fujita-hu.ac.jp
Sponsor or person
Institute
FUJITA HEALTH UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
FUJITA HEALTH UNIVERSITY
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
fujita health university Research Support Department
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562932865
f-irb@fujita-hu.ac.jp
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
| 2025 | Year | 01 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065002
