NCT02511678

Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics).

Detailed description

Participants with painful metastatic lesions involving bone who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy were offered enrollment into the study. Participants agreeing to participate will read and sign an informed consent form and thus become participants in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Participants will have one cryoablation procedure and will be followed for up to 6 months for palliation of pain, quality of life, and analgesic usage. Baseline and follow-up data will be collected for each participant via a web-based electronic data collection tool.

Conditions

• Pain
• Neoplasm Metastasis
• Bone Metastasis of Diverse Origins

Interventions

Type	Name	Description
DEVICE	Cryoablation	The application of repeated freeze and thaw cycles to the identified tissues.

Timeline

• Start date: 2016-02-15
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2015-07-30
• Last updated: 2021-07-19
• Results posted: 2019-09-04

Locations

11 sites across 2 countries: United States, France