OsteoCool Tumor Ablation Post-Market Study

NCT03249584 | Completed Results FDA Device

• 1 other identifier: MDT16075
• Study Type: interventional
• Target: 218
• Locations: 5 countries
• Sites: 16

Brief Summary

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

Conditions

Metastasis Spine; Metastasis to Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation

  From Baseline to 3 months post RF ablation

Study Arms (1)

OsteoCool™ RF Ablation

OTHER

Subjects will undergo a single OsteoCool™ RF Ablation procedure.

Device: OsteoCool™ RF Ablation

Interventions

OsteoCool™ RF Ablation DEVICE

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.

OsteoCool™ RF Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (16)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Saint Jude Medical Center

Fullerton, California, 92835, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Cumming, Georgia, 30041, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Texas (UT) Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Vascular Institute of Virginia

Woodbridge, Virginia, 22193, United States

Location

Sunnybrook Health Science Centre

Toronto, M4N 3M5, Canada

Location

Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

Location

Universitätsklinikum Leipzig AöR

Leipzig, 04103, Germany

Location

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

Location

Related 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 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.

  PMID: 33129427 RESULT

Results Point of Contact

• Title: Eric Grovender
• Organization: MedtronicNeuro

eric.a.grovender@medtronic.com

763-514-4000

Study Officials

• Sandeep Bagla, MD

  Vascular Institute of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: October 12, 2017
• Primary Completion: April 30, 2019
• Study Completion: July 17, 2020
• Last Updated: October 1, 2021
• Results First Posted: July 7, 2020

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (12); DE (1); FR (1); LU (1)