UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035597 |
|---|---|
| Receipt number | R000040562 |
| Scientific Title | The evaluation of respiratory movement of inferior vena cava filters using four dimensional-computed tomography (prospective study) |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/01/19 19:01:51 |
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Basic information
Public title
The evaluation of respiratory movement of inferior vena cava filters using four dimensional-computed tomography
(prospective study)
Acronym
Filter4D
Scientific Title
The evaluation of respiratory movement of inferior vena cava filters using four dimensional-computed tomography
(prospective study)
Scientific Title:Acronym
Filter4D
Region
| Japan |
Condition
Condition
venous thromboembolism
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the mechanism of filter fractures, caval penetration, and adjacent organ injuries by observing the respiratory movements of inferior vena cava filters on four dimensional computed tomography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The measurements of vector's values of the top and leg's tips of the filters between the expiratory and inspiratory phases on four-dimensional computed tomography in patients with filters.
Key secondary outcomes
To assess the confidential levels of caval penetration and adjacent organ injuries by filters.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
four-dimensional computed tomography (approximately 1mSv during a few seconds)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with inferior vena cava filters and the informed consent.
Key exclusion criteria
1. below the age of 20 years old
2. pregnant or possible pregnant women
3. not obtained the informed consent
4. determined as not applicable by the researchers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Koizumi |
Organization
Tokai University School of Medicine
Division name
Diagnostic Radiology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
jkoizumi@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Koizumi |
Organization
Tokai University School of Medicine
Division name
Diagnostic Radiology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
jkoizumi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Diagnostic Radiology,
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Diagnostic Radiology,
Tokai University School of Medicine
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
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
東海大学医学部付属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040562
