The STAR™ Tumor Ablation Registry

NCT ID: NCT02419703

Last Updated: 2017-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Lesions in Vertebral Bodies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients receiving Targeted Radiofrequency Ablation (t-RFA)

STAR™ Tumor Ablation System

Intervention Type DEVICE

Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STAR™ Tumor Ablation System

Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

DFINE Inc.

INDUSTRY

Sponsor Role collaborator

Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

John Muir Medical Center

Concord, California, United States

Site Status

Southern California Institute of Neurological Surgery

Escondido, California, United States

Site Status

University of California, Los Angeles

Los Angeles, California, United States

Site Status

St. Joseph's Medical Center

Stockton, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Mori Bean and Brook Radiology

Jacksonville, Florida, United States

Site Status

Medical Imaging & Therapeutics

Lady Lake, Florida, United States

Site Status

VIR Chicago

Chicago, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status

University of Tennessee

Knoxville, Tennessee, United States

Site Status

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DF-15-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Metastatic Tumor Research and Outcomes Network
NCT02830451 ACTIVE_NOT_RECRUITING