Unique ID issued by UMIN | UMIN000012564 |
---|---|
Receipt number | R000014597 |
Scientific Title | Phase II trial of embolization with NBCA-lipiodol mixture (JIVROSG-0802) |
Date of disclosure of the study information | 2013/12/12 |
Last modified on | 2018/10/31 17:41:34 |
Phase II trial of embolization with NBCA-lipiodol mixture (JIVROSG-0802)
Phase II trial of NBCA (JIVROSG-0802)
Phase II trial of embolization with NBCA-lipiodol mixture (JIVROSG-0802)
Phase II trial of NBCA (JIVROSG-0802)
Japan |
active bleeding, pseudoaneurysm, true aneurysm, vascular malformation, arteriovenous fistula, and embolization in vascular intervention
Radiology |
Others
NO
To evaluate the efficacy and safety of embolization with NBCA-lipiodol mixture.
Safety,Efficacy
Efficacy: Success rate of embolization with NBCA-lipiodol mixture
Safety: Frequency of adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Maneuver |
arterial embolization with NBCA-lipiodol
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1. Patients who will undergo arterial embolizaiton for the pathophysiologies listed below.
Active bleeding or pseudoaneurysm
True aneurysm
Vascuar malformation
Arteriovenous fistula
Arterial re-distribution
2. Difficulties in embolization with pre-existing embolic materials approved in Japan judged by radiologists.
or
Failures of embolization with pre-existing embolic materials approved in Japan.
3. Shock index < 1.5
4.Written informe consent is obtained from patients or their relatives.
1. Allergic histories for iodininated contrast medium or lipiodol.
2. CNS arteriovenous malformation
3. Cerebral aneurysm
4. DIC
5. Uncontrollable shock
6. Endoleak after aortic stent placement
7. Pregnant woman, or pegnancy is suspected
8. Radiologist judged that the patients is not suitable for the present study.
65
1st name | |
Middle name | |
Last name | Shunsuke Sugawara |
National Cancer Center Hospital
Department of Diagnostic Radiology
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-5475-5201
sugasuga_shun@yahoo.co.jp
1st name | |
Middle name | |
Last name | Shunsuke Sugawara |
National Cancer Center
Diagnostic Radiology
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-5475-5201
http://jivrosg.umin.jp/
sugasuga_shun@yahoo.co.jp
Japan Interventional Radiology In Oncology Study Group(JIVROSG)
Japan Interventional Radiology In Oncology Study Group
Other
NO
2013 | Year | 12 | Month | 12 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 30 | Day |
2014 | Year | 02 | Month | 01 | Day |
2016 | Year | 05 | Month | 20 | Day |
2016 | Year | 05 | Month | 20 | Day |
2017 | Year | 11 | Month | 08 | Day |
2017 | Year | 11 | Month | 16 | Day |
2013 | Year | 12 | Month | 12 | Day |
2018 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014597