RecruitingNCT01788410

MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine

MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating(AMIGO) Suite


Sponsor

Brigham and Women's Hospital

Enrollment

50 participants

Start Date

May 1, 2013

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this study is to provide pain relief to patients with facet joint disease or head and neck pain related to compression of a nerve root. The goal is to provide palliative care with superior efficacy and longer relief compared to current methods.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Participants must be willing and able to sign a written informed consent document.
  • Patients must have facet joint disease or pain due to a damaged or compressed nerve that would benefit from a minimally invasive image-guided procedure (i.e., adjacent to critical structures, better visualized under 3 Tesla MRI than CT)
  • Subjects must be able to adhere to the visit schedules and attend pre and post imaging.
  • Participants must be at least 18 years of age
  • Participants must have an estimated life expectancy of \>8 weeks in the opinion of the clinician.
  • Patients with radiculopathy must have the cause of pain confirmed by a nerve block within 3 months prior to ablation

Exclusion Criteria2

  • Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate \<60ml/min, metal clips)
  • Pregnant or breastfeeding woman are excluded from this research.

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Interventions

PROCEDURECryoablation under image guidance

Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.

DEVICEMRI Seednet Cryotherapy System (Galil Medical)

Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT01788410


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