OsteoCool Tumor Ablation Post-Market Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009477
NCT ID: NCT03249584
Sponsor Protocol Number: MDT16075
About this study
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region.
- 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 (Europe and Canada only) – 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 not more than two sites 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.
Exclusion Criteria:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jonathan Morris, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available