MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Contraindications to MRI and Gadolinium- (i.e. estimated Glomerular Filtration Rate <60ml/min, metal clips)
Pregnant or breastfeeding woman are excluded from this research.
Trial population
Potential subjects must be 18 years of age and will be selected among patients who have a pain related to facet joint disease, nerve degeneration or compression. Subjects must benefit from a minimally invasive treatment option.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cryoablation under image guidance
Procedure/SurgeryObserving 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)
DeviceObserving efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Cryoablation under image guidance2 interventions
Trial outcomes
Primary outcomes
1
Eliminating radicular pain or pain caused by spinal disease.
We will be grading patients pain using the "Brief Pain Inventory" pre-ablation and 1 month post-ablation.
Time frame
1 monthSecondary outcomes
1
Long term radicular pain relief
We are attempting to produce long-term pain relief through cryoablation.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov