Metastasis SpineOPuS OneNCT03249584
OsteoCool Tumor Ablation Post-Market Study
A study testing OsteoCool™ RF Ablation in people with Metastasis Spine and Metastasis to Bone, run by MedtronicNeuro at 16 sites in 5 countries.
Trial summary
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasis Spine, Metastasis to Bone
- What is being tested?
- OsteoCool™ RF Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 12 Oct 2017to 17 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
- A. Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors - no restrictions on location of lesion
- Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
- Localized pain resulting from no more than two sites total of metastatic disease
- Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors)
- Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
- At least 18 years old at the time of informed consent
Who cannot join
- A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)
- Use of OsteoCool in vertebral body levels C1-C7
- Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone
- Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection
- Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise
- Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression
Show all 11Show fewer
- Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or mixed origin are eligible for the study
- Pregnant, breastfeeding, or plan to become pregnant during the study duration
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*
- Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation
- Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States12 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Northside Hospital
Cumming, Georgia, 30041
University of Texas (UT) Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27705
Saint Jude Medical Center
Fullerton, California, 92835
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Renown Regional Medical Center
Reno, Nevada, 89502
Mayo Clinic
Rochester, Minnesota, 55905
Moffitt Cancer Center
Tampa, Florida, 33612
Vascular Institute of Virginia
Woodbridge, Virginia, 22193
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
France1 site
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg
About this study
Official title: OsteoCool Tumor Ablation Post-Market Study (OPuS One)
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
Read the detailed description
The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and benign bone tumors such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.
- Conditions
- Metastasis Spine, Metastasis to Bone
- Being tested
- OsteoCool™ RF Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteoCool™ RF AblationDevice
The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas.
| Study group | Role | What they receive |
|---|---|---|
| OsteoCool™ RF Ablation | Other | Subjects will undergo a single OsteoCool™ RF Ablation procedure. Receives: Device: OsteoCool™ RF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
Measured: From Baseline to 3 months post RF ablation
Secondary outcomes (1)
Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation
Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.
Measured: From Baseline to 3 months post RF ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start12 Oct 2017
- Primary completion30 Apr 2019
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastasis SpineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Enrollment/Baseline visit, OsteoCool procedure visit and 5 post-procedure visits (3 days, 1 week, 1-, 3-, and 6-month clinic visits) and a final post-procedure study visit (12 months) for a total of 8 study related visits.
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandeep Bagla, MD, Principal investigator, Vascular Institute of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249584
- Sponsor's protocol ID
- MDT16075
- Acronym
- OPuS One
- Status last verified
- Sep 2021
- First submitted
- 11 Aug 2017
- Last updated
- 1 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Hoh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014.
PubMed 33129427
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OsteoCool Tumor Ablation Post-Market Study (OPuS One)
- ClinicalTrials.gov ID
- NCT03249584
- Acronym / sponsor ID
- OPuS One / MDT16075
- Conditions
- Metastasis Spine, Metastasis to Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
Detailed description
The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and benign bone tumors such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrollment/Baseline visit, OsteoCool procedure visit and 5 post-procedure visits (3 days, 1 week, 1-, 3-, and 6-month clinic visits) and a final post-procedure study visit (12 months) for a total of 8 study related visits.
| Arm | Type | Receives |
|---|---|---|
| OsteoCool™ RF Ablation | Other | Device: OsteoCool™ RF AblationSubjects will undergo a single OsteoCool™ RF Ablation procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
- A. Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors - no restrictions on location of lesion
- Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
- Localized pain resulting from no more than two sites total of metastatic disease
- Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors)
Key exclusion criteria (11 listed)
- A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)
- Use of OsteoCool in vertebral body levels C1-C7
- Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone
- Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection
- Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise
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 |
|---|---|---|
| OsteoCool™ RF AblationThe OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas. | Device | OsteoCool™ RF Ablation |
Primary outcome
Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
Time frame: From Baseline to 3 months post RF ablation
Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
1 secondary outcome
Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation
Time frame: From Baseline to 3 months post RF ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33129427Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Hoh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014.
- Individual participant dataSharing planned: No
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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
Vascular Institute of Virginia
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsteoCool™ RF Ablation in people with Metastasis Spine and Metastasis to Bone, run by MedtronicNeuro at 16 sites in 5 countries.
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 7 inclusion and 11 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 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada, France, Germany, Luxembourg. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation (time frame: From Baseline to 3 months post RF ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249584, which also lists 1 linked publication.
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 1 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.