Recruiting

Cryoablation

Sponsor:

Brigham and Women's Hospital

Code:

NCT01788410

Conditions

Facet Joints; Degeneration

Neuropathy

Neuralgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryoablation under image guidance

MRI Seednet Cryotherapy System (Galil Medical)

Study Details

Brief 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.

Conditions

Facet Joints; Degeneration

Neuropathy

Neuralgia

Study ID

NCT01788410

Start date

May, 2013

Status verified date

Aug, 2023

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Cryoablation under image guidance

Patients with facet joint disease, or compressed or damaged nerve roots causing pain in the head, neck or spine. Procedures performed with MRI Seednet Cryotherapy System (Galil Medical).

Interventions

Cryoablation 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.

MRI 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.

Primary outcome measure

  • Eliminating radicular pain or pain caused by spinal disease. [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Thomas Lee, MD

(617) 732-7260tchlee@partners.org

Danielle Chamberlain, BS, RT(R)

617-525-8596dchamberlain1@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Thomas Lee, M.D.

617-732-7260tchlee@partners.org

Danielle Chamberlain, B.S, R.T.(R)

617-525-8596dchamberlain1@partners.org

Principal Investigator:

Thomas C. Lee, M.D

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 8, 2023

Last verified

Aug, 2023

Keywords

  • Cryoablation
  • Nerves
  • Facet joint
  • Pain
  • Neuralgia
  • Neuropathy
  • Image-guided

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-08-08.