The STAR™ Tumor Ablation Registry

Metastatic Lesions in Vertebral Bodies Clinical Trial

Official title:

The STAR™ Tumor Ablation Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02419703
• Other study ID #: DF-15-03
• Status: Terminated
• Phase: N/A
• First received: April 10, 2015
• Last updated: April 10, 2017
• Start date: October 2015
• Est. completion date: March 20, 2017

Study information

• Verified date: April 2017
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Registry collecting data on use of The STAR™ Tumor Ablation System.

Description:

The STAR Prospective Registry is an observational registry to gather clinical safety and outcome data in patients with painful spinal metastases in the thoracolumbar spine (T1-L5) following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.

• Have signed informed consent

Exclusion Criteria:

• Subjects under 18 years old

• Subjects with heart pacemakers, or other electronic device implants

• Subjects intended for t-RFA in vertebral body levels C1-7

Related Conditions & MeSH terms

• Metastatic Lesions in Vertebral Bodies

Intervention

Device:
• STAR™ Tumor Ablation System
Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.

Locations

Country	Name	City	State
United States	VIR Chicago	Chicago	Illinois
United States	John Muir Medical Center	Concord	California
United States	University of Colorado	Denver	Colorado
United States	Southern California Institute of Neurological Surgery	Escondido	California
United States	Mori Bean and Brook Radiology	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Tennessee	Knoxville	Tennessee
United States	Medical Imaging & Therapeutics	Lady Lake	Florida
United States	University of California, Los Angeles	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Mayo Clinic	Rochester	Minnesota
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	Washington University	St. Louis	Missouri
United States	St. Joseph's Medical Center	Stockton	California
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.	DFINE Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief (Numerical Rating Pain Scale), post t-RFA	measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)	1 month
Secondary	Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)	measured by the FACT G7 & Numerical Rating Pain Scale	1 week, 1 month, 3 month, 6 month, 12 month