NIPH Clinical Trials Search

UMIN ID: C000000041

Registered date:06/08/2005

A phase I/II study of percutaneous vertebroplasty (JIVROSG-0202)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMalignant vertebral bone tumor.
Date of first enrollment2003/02/01
Target sample size33
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the vertebral body involved by malignant tumor and cement is injected.


Primary OutcomeAdverse events
Secondary OutcomePain evaluated by Visual Analogue Scale (VAS).

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Bleeding time more than 5 minutes. 2) Fever above 38 degrees Celsius. 3) Cardiac failure requiring medication. 4) Active inflammation in vertebrae 5) Severely collapsed vertebrae (less than one third of normal height). 6) No severe pain (less than 2 of VAS). 7) Unable to keep prone position for 1 hour. 8) Necessity of procedure for more than 5 contiguous vertebral bodies. 9) Necessity of single session procedure for more than 4 vertebral bodies. 10) Severe drug allergy. 11) Pregnancy.

Related Information


public contact
Name Yasuaki Arai
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
Affiliation JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Ken Kobayashi
Address 13-1, Takaramachi, Kanazawa 920-8641, Japan Japan
Telephone 076-265-2323
Affiliation Kanazawa University Graduate School of Medicine Department of Radiology