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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022918
Receipt No. 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

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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
Email 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
Email junryuhei@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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