The STAR Prospective Clinical Series

NCT ID: NCT02217150

Last Updated: 2017-01-20

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

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-04-30

Brief Summary

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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 STARâ„¢ Tumor Ablation System.

Detailed Description

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Conditions

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Metastasis to Vertebral Column

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metastatic Lesions to the spine

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* The STARâ„¢ 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DFINE Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandeep Bagla, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Alexandria Hospital

Locations

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Palomar Pomerado Health System

Escondido, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Suburban Hospital

Bethesda, Maryland, United States

Site Status

Austin Radiological Associates

Austin, Texas, United States

Site Status

St. Mark's Hospital

Salt Lake City, Utah, United States

Site Status

Inova Alexandria Hospital

Alexandria, Virginia, United States

Site Status

Providence Sacred Heart Hospital

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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20130370

Identifier Type: OTHER

Identifier Source: secondary_id

PCS

Identifier Type: -

Identifier Source: org_study_id

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