NCT02217150

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

August 12, 2014

Last Update Submit

January 18, 2017

Conditions

Metastasis to Vertebral Column

Outcome Measures

Primary Outcomes (1)

  • Change in Pain

    Mean change from baseline in worst pain score per NRPS at one month

    1 month

Secondary Outcomes (3)

  • Change in Quality of Life

    3 months

  • Change if Quality of Life

    3 months

  • Change in Function

    3 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation System.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Palomar Pomerado Health System

Escondido, California, 92027, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Austin Radiological Associates

Austin, Texas, 78759, United States

Location

St. Mark's Hospital

Salt Lake City, Utah, 84107, United States

Location

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

Providence Sacred Heart Hospital

Spokane, Washington, 99204, United States

Location

Study Officials

  • Sandeep Bagla, MD

    Inova Alexandria Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

April 1, 2016

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

US(8)