Metastasis to Vertebral ColumnPCSNCT02217150
The STAR Prospective Clinical Series
An observational study of Metastasis to Vertebral Column, run by DFINE Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metastasis to Vertebral Column
- How many people
- 50 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2013to Apr 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation System.
Who may be able to join
- The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Inova Alexandria Hospital
Alexandria, Virginia, 22304
Austin Radiological Associates
Austin, Texas, 78759
Suburban Hospital
Bethesda, Maryland, 20814
Palomar Pomerado Health System
Escondido, California, 92027
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California
Los Angeles, California, 90033
St. Mark's Hospital
Salt Lake City, Utah, 84107
Providence Sacred Heart Hospital
Spokane, Washington, 99204
About this study
Official title: The DFINE STAR™ Tumor Ablation Prospective Clinical Series
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.
- Conditions
- Metastasis to Vertebral Column
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Mean change from baseline in worst pain score per NRPS at one month
Measured: 1 month
Secondary outcomes (3)
Change in Quality of Life
Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP)
Measured: 3 months
Change if Quality of Life
Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7)
Measured: 3 months
Change in Function
Change from baseline at each visit using Modified Oswestry Disability Index (MODI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasis to Vertebral ColumnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- DFINE Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandeep Bagla, MD, Principal investigator, Inova Alexandria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217150
- Sponsor's protocol ID
- PCS
- Other IDs
- 20130370
- Acronym
- PCS
- Status last verified
- Jan 2017
- First submitted
- 12 Aug 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DFINE STAR™ Tumor Ablation Prospective Clinical Series
- ClinicalTrials.gov ID
- NCT02217150
- Acronym / sponsor ID
- PCS / PCS
- Conditions
- Metastasis to Vertebral Column
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- DFINE Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation System.
Key inclusion criteria (1 listed)
- The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Key exclusion criteria (2 listed)
- The device is contraindicated in subjects with heart pacemakers, or other electronic device implants.
- The device is contraindicated in vertebral body levels C1-7.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pain
Time frame: 1 month
Mean change from baseline in worst pain score per NRPS at one month
3 secondary outcomes
Change in Quality of Life
Time frame: 3 months
Change if Quality of Life
Time frame: 3 months
Change in Function
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Bagla, MD principal investigator
Inova Alexandria Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastasis to Vertebral Column, run by DFINE Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.