UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018584 |
|---|---|
| Receipt number | R000021505 |
| Scientific Title | Evaluation of coil embolization for pulmonary arteriovenous malformation using 4D-CT |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2017/08/01 20:19:28 |
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Basic information
Public title
Evaluation of coil embolization for pulmonary arteriovenous malformation using 4D-CT
Acronym
Evaluation of coil embolization for pulmonary arteriovenous malformation using 4D-CT
Scientific Title
Evaluation of coil embolization for pulmonary arteriovenous malformation using 4D-CT
Scientific Title:Acronym
Evaluation of coil embolization for pulmonary arteriovenous malformation using 4D-CT
Region
| Japan |
Condition
Condition
pulmonary arteriovenous malformation
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of coil embolization for pulmonary arteriovenous malformation using 4D-CT
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
efficacy
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
4D-CT is performed to evaluate the efficasy of coil embolization for pulmonary arteriovenous malformation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with coil embolization of pulmonary arteriovenous malformation
2) Floow-up CT was performed
Key exclusion criteria
1) History of allergy of iodinated contrast material
2) Active asthma
3) Estimated Glomerular Filtration Rate < 30min/mil (excluding dialysis)
4) Not eligible determined by the responding physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seishi nakatsuka |
Organization
Keio University School of Medicine
Division name
Diagnostic Radiology
Zip code
Address
35 shinanomachi Shinjuku-ku Tokyo
TEL
+81-33353-1211
nakatsuk@a2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Inoue |
Organization
Keio University School of Medicine
Division name
Diagnostic Radiology
Zip code
Address
35 shinanomachi Shinjuku-ku Tokyo
TEL
+81-33353-1211
Homepage URL
inomasa@mac.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 07 | Day |
Last modified on
| 2017 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021505
