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

Description

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.

Study Start Date

May 2013

Estimated Completion Date

May 2018

Interventions

  • Procedure: Cryoablation under image guidance
  • Device: MRI Seednet Cryotherapy System

Specialties

  • Neurology: Neuropathy/Myopathy,Pain Medicine
  • Radiology: MRI
  • Orthopedics: Arthritis/Rheumatology,Pain Management
  • Pain Management: Neurology,Orthopedics

MeSH Terms

  • Cryoablation
  • Facet Joints
  • MRI Seednet Cryotherapy Syste
  • Neuralgia

Study ID

Brigham and Women's Hospital -- 2012-P-002071

Status

Unknown

Trial ID

NCT01788410

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

50

Sponsor

Brigham and Women's Hospital

Inclusion Criteria

  • 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 Criteria

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Thomas Lee MD 617-732-7260 tchlee@partners.org

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