UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014360
Receipt No. R000016164
Scientific Title Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils: a phase II study (SCIRO-1402)
Date of disclosure of the study information 2014/07/01
Last modified on 2017/06/26

* 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 Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils: a phase II study (SCIRO-1402)
Acronym Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils (SCIRO-1402)
Scientific Title Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils: a phase II study (SCIRO-1402)
Scientific Title:Acronym Venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils (SCIRO-1402)
Region
Japan

Condition
Condition Pulmonary arteriovenous malformation
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of venous sac embolization for pulmonary arteriovenous malformations using Hydrocoils
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes efficacy
Key secondary outcomes adverse event
image findings

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 Following doing pulmonary arteriography, venous sac embolization of pulmonary arteriovenous mulformations is to be performed using Hydrocoil. Embolization is performed in 1 procedure.
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) Pulmonary arteriovenous malformation exists on chest CT (<= 3mm thickness)
2) Meets one or more following criteria.
a) history of brain infarction and/or abscess
b) history of transient ischemic attack
c) history of hemoptysis
d) history of hypoxemia
e) diameter of feeding pulmonary artery >= 3mm.
3) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions.
4) Performans status of 0-2.
5) Life expectancy >= 13 months.
Key exclusion criteria 1) History of allergy of iodinated contrast material
2) Active asthma
3) Single lung.
4) Inpaired pulmonary function of contralateral lung.
5) Pulmonary hypertension.
6) Estimated Glomerular Filtration Rate < 30min/mil (excluding dialysis)
7) Child Pugh score >= 9
8) Heart failure (NYHA >= III)
9) Uncontrolable malignant disease.
10) Active infection or active inflammatory process
11) Body temperature of 38 degree or more.
12) Pregnant.
13) Not eligible determined by the responding physician.
Target sample size 21

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 city
TEL +81-86-235-7315
Email susumu@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Iguchi
Organization Okayama University Hospital
Division name Department of Radiology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL +81-86-235-7315
Homepage URL
Email iguchi@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Department of Radiology, Okayama University Medical School
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
2014 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 No longer recruiting
Date of protocol fixation
2014 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2014 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
2014 Year 06 Month 24 Day
Last modified on
2017 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.