Metastatic Lesions in Vertebral BodiesNCT02419703
The STAR™ Tumor Ablation Registry
An observational study of Metastatic Lesions in Vertebral Bodies, run by Merit Medical Systems, Inc. at 15 sites in United States.
Trial summary
Registry collecting data on use of The STAR™ Tumor Ablation System. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Metastatic Lesions in Vertebral Bodies
- What is being tested?
- STAR™ Tumor Ablation System
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2015to 20 Mar 2017
- How long will I take part?
- 12 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
VIR Chicago
Chicago, Illinois
John Muir Medical Center
Concord, California, 94520
University of Colorado
Denver, Colorado, 80045
Southern California Institute of Neurological Surgery
Escondido, California, 92025
Mori Bean and Brook Radiology
Jacksonville, Florida, 32216
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Tennessee
Knoxville, Tennessee, 37920
Medical Imaging & Therapeutics
Lady Lake, Florida, 32159
University of California, Los Angeles
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin
Mayo Clinic
Rochester, Minnesota, 55905
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Washington University
St Louis, Missouri, 63110
St. Joseph's Medical Center
Stockton, California, 95204
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Registry collecting data on use of The STAR™ Tumor Ablation System.
Read the detailed 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.
- Conditions
- Metastatic Lesions in Vertebral Bodies
- Being tested
- STAR™ Tumor Ablation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR™ Tumor Ablation SystemDevice
Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Targeted Radiofrequency Ablation (t-RFA) | Not described Receives: Device: STAR™ Tumor Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief (Numerical Rating Pain Scale), post t-RFA
measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)
Measured: 1 month
Secondary outcomes (1)
Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)
measured by the FACT G7 \& Numerical Rating Pain Scale
Measured: 1 week, 1 month, 3 month, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startOct 2015
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Why it stopped: Difficulty Enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lesions in Vertebral BodiesStudies 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
- 65 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DFINE Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419703
- Sponsor's protocol ID
- DF-15-03
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2015
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STAR™ Tumor Ablation Registry
- ClinicalTrials.gov ID
- NCT02419703
- Acronym / sponsor ID
- DF-15-03
- Conditions
- Metastatic Lesions in Vertebral Bodies
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty Enrolling
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- DFINE Inc.
- Study start
- Oct 2015
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 17 Apr 2015 (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.
Registry collecting data on use of The STAR™ Tumor Ablation System.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Targeted Radiofrequency Ablation (t-RFA) | – | Device: STAR™ Tumor Ablation System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR™ Tumor Ablation SystemTargeted Radiofrequency ablation of painful metastatic tumor in the vertebral body. | Device | Patients receiving Targeted Radiofrequency Ablation (t-RFA) |
Primary outcome
Pain relief (Numerical Rating Pain Scale), post t-RFA
Time frame: 1 month
measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)
1 secondary outcome
Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)
Time frame: 1 week, 1 month, 3 month, 6 month, 12 month
Results and safety
The study was stopped early (reason given: Difficulty Enrolling). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Lesions in Vertebral Bodies, run by Merit Medical Systems, Inc. at 15 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 was stopped early (reason given: Difficulty Enrolling). Results are not available in the source record.
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?
Pain relief (Numerical Rating Pain Scale), post t-RFA (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 12 Apr 2017.