UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012194
Receipt No. R000014049
Scientific Title Safety cofirmatory study for Percutaneous cryoablation of vascular malformations
Date of disclosure of the study information 2013/11/01
Last modified on 2015/11/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Safety cofirmatory study for Percutaneous cryoablation of vascular malformations
Acronym SCIRO-1303 study
Scientific Title Safety cofirmatory study for Percutaneous cryoablation of vascular malformations
Scientific Title:Acronym SCIRO-1303 study
Region
Japan

Condition
Condition vascular malformation
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the safety for the cryoablation of vascular malformations.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse Events
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 Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Percutaneous cryoablation
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
13 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Written informed consent is obtained by patient or parents.
2)Survival more than three months from a registration day can be expected.
3)Diagnosed as vascular malformation clinically(Characteristic image findings, US: hypoecho, MRI T2WI: high signal, phlebolith, skin color change, soft mass and so on)
4)Symptom (pain, swelling) thought to be due to vascular malformation is present. Or the lesion is progressive even if asymptomatic.
5) The lesion is apart from a vital organ or an important structure.
6) Operation is out of adaption or patient does not hope operation.
7) Medical treatment would not effect sufficiency.
8) Main organ function is kept.
a. White blood-cell count >2,500/mm3
b. Platelet count >50,000/mm3
c. Hemoglobin >7.0g/mm3
d. Creatinin <2.0mg/dl
e. Total bilirubin <3.0mg/dl
Key exclusion criteria 1) Under 13 years old.
2) Patients have severe comorbidities as follows:
a. Uncontroled malignant tumor.
b. Serious lung disease.
c. Serious heart trouble.
d. Serious liver disease.
e. Severe active inflammation and infectious disease.
f. Poor control diabetes.
g. Immunocompromised state including the whole steroid therapy.
h. Case having complications considered to disturb completion of the cryoablation.
4) Past history of radiation exposure to the lesion.
5) Probe insertion can't be performed safely.
6) Clinical clear bleeding tendency (PT-INR >=1.5)
7) Drugs such as antiplatelet agent, anticoagulant, thrombolytic agent can't be ceased temporarily.
8) Being pregnant or may be pregnant.
9) Considered unsuitable for being enrolled in this clinical trial by a attending physician.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Kanazawa
Organization Okayama University Hospital
Division name Department of Radiology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL +81-86-235-7313
Email susumu@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Fujiwara
Organization Okayama University Hospital
Division name Department of Radiology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL +81-86-235-7313
Homepage URL
Email hirofujiwar@gmail.com

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion Science
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
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
2013 Year 11 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 Completed
Date of protocol fixation
2013 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 15 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
2013 Year 11 Month 01 Day
Last modified on
2015 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014049

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.