OsteoCool Tumor Ablation Post-Market Study

Metastasis to Bone Clinical Trial

— OPuS One  

Official title:

OsteoCool Tumor Ablation Post-Market Study (OPuS One)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249584
• Other study ID #: MDT16075
• Status: Completed
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: July 17, 2020

Study information

• Verified date: September 2021
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 17, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region

2. 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

3. Report worst pain score =4/10 at the target treatment site within the past 24 hours

4. Localized pain resulting from no more than two sites total of metastatic disease

5. Have Karnofsky score =40 at enrollment (not applicable for subjects with benign bone tumors)

6. Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls

7. At least 18 years old at the time of informed consent

Exclusion Criteria:

1. A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)

2. Use of OsteoCool in vertebral body levels C1-C7

3. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone

4. Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection

5. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise

6. Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression

7. 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

8. Pregnant, breastfeeding, or plan to become pregnant during the study duration

9. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*

10. 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.

Related Conditions & MeSH terms

• Metastasis Spine
• Metastasis to Bone
• Neoplasm Metastasis

Intervention

Device:
• OsteoCool™ RF Ablation
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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Science Centre	Toronto
France	Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil	Strasbourg
Germany	Universitätsklinikum Leipzig AöR	Leipzig
Luxembourg	Centre Hospitalier de Luxembourg	Luxembourg
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northside Hospital	Cumming	Georgia
United States	University of Texas (UT) Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Saint Jude Medical Center	Fullerton	California
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona
United States	Renown Regional Medical Center	Reno	Nevada
United States	Mayo Clinic	Rochester	Minnesota
United States	Moffitt Cancer Center	Tampa	Florida
United States	Vascular Institute of Virginia	Woodbridge	Virginia
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Luxembourg, 

References & Publications (1)

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 Höh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoC — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline to 3 months post RF ablation
Secondary	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.	From Baseline to 3 months post RF ablation