NIPH Clinical Trials Search

UMIN ID: C000000039

Registered date:05/08/2005

A phase I/II study of uterine artery embolization using gelatine sponge for symptomatic uterine leiomyoma (JIVROSG-0302)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedSymptomatic uterine leimoyoma
Date of first enrollment2004/03/01
Target sample size33
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Bilateral uterine arteries are embolized with gelatine sponge particles using microcatheter system inserted by Seldinger's technique. The embolization is terminated when the stasis of blood flow in the ascending branch of uterine arteries is observed.


Primary OutcomeAdverse events
Secondary OutcomeImprovement of symptoms, decrease of the volume of leiomyoma, changes in ovarian function, length of hospital stay.

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
Include criteria
Exclude criteria1) Pregnant, nursing, or desiring future pregnancy. 2) Active pelvic inflammatory disease. 3) Pelvic malignancy. 4) Previous hormonal therapy within 12 weeks. 5) Contraindication to MRI. 6) Contraindication to iodized contrast material. 7) Uncontrolled cardiac, respiratory, gastrointestinal, or nervous disorders. Uncontrolled diabetes, hypertension, or infection. 8) Adenomyosis confirmed with MRI.

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 Miyuki Sone
Address 19-1, Uchimaru, Morioka 020-8505, Japan Japan
Telephone 019-651-5111
Affiliation Iwate Medical University Department of Radiology