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OsteoCool Tumor Ablation Post-Market Study

NCT03249584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2021-10-01

Study results available
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Summary

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

Conditions

  • Metastasis Spine
  • Metastasis to Bone

Interventions

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.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Sandeep Bagla, MD · Vascular Institute of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2019-04-30
Completion
2020-07-17
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Luxembourg

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03249584 on ClinicalTrials.gov