UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046478 |
|---|---|
| Receipt number | R000049048 |
| Scientific Title | The development of radiation protection shield for catheter-based treatment of structural heart disease (for echocardiologists and anesthesiologists) |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/12/27 09:41:55 |
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Basic information
Public title
The development of radiation protection shield for catheter-based treatment of structural heart disease (for echocardiologists and anesthesiologists)
Acronym
The development of radiation protection shield
Scientific Title
The development of radiation protection shield for catheter-based treatment of structural heart disease (for echocardiologists and anesthesiologists)
Scientific Title:Acronym
The development of radiation protection shield
Region
| Japan |
Condition
Condition
structural heart disease
Classification by specialty
| Cardiology | Radiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop a radiation protection shield which allow echocardiologists and anesthesiologists operate easily
Basic objectives2
Others
Basic objectives -Others
usability/radiation protection
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of usability and physical burden depending on the size of the side hole of the radiation protection shield
Key secondary outcomes
Surface radiation dose in target organs
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
echocardiologists and anesthesiologists of Teikyo University Hospital
Key exclusion criteria
none
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akihisa |
| Middle name | |
| Last name | Kataoka |
Organization
Teikyo University
Division name
Department of Medicine
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
+81-3-3964-1211
kataoaki@sd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Akihsa |
| Middle name | |
| Last name | Kataoka |
Organization
Teikyo University Hospital
Division name
Department of Medicine
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
TEL
+81-3-3964-1211
Homepage URL
kataoaki@sd5.so-net.ne.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
TERUMO LIFE SCIENCE FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606, Japan
Tel
+81-3-3964-7256
turb-office@teikyo-u.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
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2021 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049048
