A phase I/II study of percutaneous radiofrequency ablation for malignant tumor in the pelvis (JIVROSG-0204)

UMIN ID: C000000046

Registered date:06/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Symptomatic intrapelvic malignant tumor
• Date of first enrollment: 2005/06/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Radiofrequency ablation needle is percutaneouly inserted into the intrapelvic malignant tumor and radiofrequency ablation is performed.

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Improvement of symptom measured by Visual Analogue Scale at 1 week after the procedure.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) No symptom or VAS of less than 3. 2) Cardiac pacemaker. 3) Artery or nerve along the puncture route. 4) Lesion or target area adjacent to critical organs. 5) Infection in the target area. 6) Pregnancy.

Related Information

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