UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050293 |
|---|---|
| Receipt number | R000057229 |
| Scientific Title | A pilot study of a device that monitors the pressure and the remaining volume of irrigation fluids during an endovascular surgery. |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2023/02/09 09:22:45 |
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Basic information
Public title
A study of the efficacy of the device that monitors the pressure and the remainders of the irrigation fluids in intravascular surgery.
Acronym
A study of a device that monitors the irrigation fluids in endovascular surgery.
Scientific Title
A pilot study of a device that monitors the pressure and the remaining volume of irrigation fluids during an endovascular surgery.
Scientific Title:Acronym
A pilot study of a device that monitors the pressure and the remaining volume of the irrigation fluids.
Region
| Japan |
Condition
Condition
neuroendovascular diseases
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce the risk of blood clot formations in angiographic catheters, arterial embolisms, and post-op complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of cases in which no one notices low irrigation pressure or a small amount of volume left in the irrigation bag.
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To use a test device
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
Any patient who undergoes an endovascular surgery
Key exclusion criteria
In case a patient or his/her legal guardian does not consent to participating in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Miyamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Neurosurgery
Zip code
4130012
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
TEL
0557819171
smiyamoto@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Miyamoto |
Organization
International University of Health and Welfare Atami Hospital
Division name
Department of Neurosurgery
Zip code
4130012
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
TEL
0557819171
Homepage URL
smiyamoto@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
International University of Health and Welfare Atami Hospital
Address
13-1 Higashikaigancho Atami City, Shizuoka, Japan
Tel
0557819171
smiyamoto@iuhw.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
| 2023 | Year | 02 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057229
