Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

Pain Clinical Trial

Official title: Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

Status Withdrawn

Clinical Trial Summary

This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors.

Clinical Trial Description

Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy and radiation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney). Radiation therapy, also called radiotherapy, uses carefully targeted doses of high-energy radiation to kill cancer cells. Radiation is used to treat many kinds of cancer. Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool. ;

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Pain

• NCT number: NCT01461252
• Study type: Interventional
• Source: Boston Scientific Corporation
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 2013
• Completion date: March 2014