UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Embolization using Imipenem(TIENAM) for refractory ulcer which cause is micro AVM
Title of the study (Brief title)	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	Shinichi Ota
Organization	Shiga University of Medical Science
Division name	Dept. of Radiology
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	Shinichi Ota
Organization	Shiga University of Medical Science
Division name	Dept. of Radiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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