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

UMIN ID: C000000039

Registered date:05/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Symptomatic uterine leimoyoma
• Date of first enrollment: 2004/03/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Improvement of symptoms, decrease of the volume of leiomyoma, changes in ovarian function, length of hospital stay.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1) 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

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare