UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062213 |
|---|---|
| Receipt number | R000071196 |
| Scientific Title | Evaluation of the clinical usability of a novel guidewire fixation device in percutaneous catheter treatment. |
| Date of disclosure of the study information | 2026/07/12 |
| Last modified on | 2026/07/11 21:31:22 |
* 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 clinical usability of a novel guidewire fixation device in percutaneous catheter treatment.
Acronym
Evaluation of the clinical usability of a novel guidewire fixation device in percutaneous catheter treatment.
Scientific Title
Evaluation of the clinical usability of a novel guidewire fixation device in percutaneous catheter treatment.
Scientific Title:Acronym
Evaluation of the clinical usability of a novel guidewire fixation device in percutaneous catheter treatment.
Region
| Japan |
Condition
Condition
30 cases using a new guidewire fixation device
Classification by specialty
| Cardiology | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Primary Endpoint
The following items will be evaluated via a questionnaire to assess the ease of use and satisfaction with the new guidewire fixation device.
Ease of Use Evaluation
Ease of insertion and removal
Presence or absence of interference during use
Impact on the procedure (cumbersome/convenient)
Satisfaction Assessment
Overall satisfaction
Willingness to continue using the device
Willingness to recommend the device to others
The assessment method will use a 5-point Likert scale.
Translated with DeepL.com (free version)
Key secondary outcomes
These will be evaluated as secondary endpoints.
1) Market Research
Device cost
Whether or not the device continues to be used
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Survey
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Be a practitioner who will actually use the novel guidewire fixation device being evaluated in this study.
2) Be able to complete the questionnaire administered after using the device.
3) Have provided written informed consent.
Key exclusion criteria
If you meet any of the following criteria, you are not eligible to participate in this study.
1) If the researcher determines that your participation in this study is inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SASO |
| Middle name | |
| Last name | TAKASHI |
Organization
Mie University Hospital
Division name
Department of Clinical Engineering
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
0592321111
sasou.takashi@gmail.com
Public contact
Name of contact person
| 1st name | TAKASHI |
| Middle name | |
| Last name | SASO |
Organization
Mie University Hospital
Division name
Department of Clinical Engineering
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
0592321111
Homepage URL
sasou.takashi@gmail.com
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
TAKASHI SASO
Funding Source
Organization
Mie University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Mie University Hospital
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital
Address
2-174 Edobashi, Tsu City, Mie
Tel
0592321111
sasou.takashi@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
滋賀県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 07 | Month | 11 | Day |
Last modified on
| 2026 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071196
