The STAR Prospective Clinical Series (PCS)

DFINE

Status: Completed

Conditions: Metastasis to Vertebral Column

Study type: Observational

Funder types: Industry

Identifiers

NCT02217150

20130370 (Other Identifier)

PCS

Details and patient eligibility

About

Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

Enrollment: 50 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Exclusion criteria

• The device is contraindicated in subjects with heart pacemakers, or other electronic device implants.
• The device is contraindicated in vertebral body levels C1-7.

Trial design

50 participants in 1 patient group

Metastatic Lesions to the spine

Description:

Patients over the age of 18 receiving treatment using the DFINE Inc. STAR tumor ablation system for palliation of painful metastases of the spine.