UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022918 |
|---|---|
| Receipt number | R000026285 |
| Scientific Title | Embolization using Imipenem(TIENAM) for refractory ulcer which cause is micro AVM |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2018/06/14 12:41:20 |
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Basic information
Public title
Embolization using Imipenem(TIENAM) for refractory ulcer which cause is micro AVM
Acronym
Embolization using Imipenem for refractory ulcer
Scientific Title
Embolization using Imipenem(TIENAM) for refractory ulcer which cause is micro AVM
Scientific Title:Acronym
Embolization using Imipenem for refractory ulcer
Region
| Japan |
Condition
Condition
refractory ulcer
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and the efficiency of Imipenem prospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Successful rate of embolization by Imipenem
2. Embolic effect of Imipenem for target vessels
3. Rate of adverse effect or complications
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
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.5g Imipenem is dissolved with 10ml no-ionic iodine contract media.
Inject the Imipenem solution until well-enhanced area of the ulcer disappear on DSA.
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. Refractory ulcer which cause is micro AVM.
2. It is difficult to embolize the vessel using an embolic material which is commercially available in Japan.
3. The patient has already given Informed consent.
Key exclusion criteria
1. Refractory ulcer which cause is not micro AVM.
2. Hypersensitive patient with iodine contrast media or Carbapenem
3. Doctors judge a patient is inadequate for this study.
4. Patient under age.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Ota |
Organization
Shiga University of Medical Science
Division name
Dept. of Radiology
Zip code
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2288
junryuhei@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Ota |
Organization
Shiga University of Medical Science
Division name
Dept. of Radiology
Zip code
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2288
Homepage URL
junryuhei@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
| 2016 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026285
