Actively Recruiting
MRI-Guided Cryoablation of Head, Neck and Spine Nerves and Facets Using the Advanced Multimodality Image Guided Operating (AMIGO) Suite
Led by Brigham and Women's Hospital · Updated on 2023-08-08
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of MRI-guided cryoablation to relieve pain in patients suffering from facet joint disease or head and neck pain caused by nerve root compression. The study explores whether this minimally invasive approach offers better and longer-lasting pain relief compared to current treatments, focusing on palliative care for nerve-related pain conditions such as neuropathy and neuralgia. The treatment involves cryoablation, which disables pain-transmitting nerves by freezing them using the MRI Seednet Cryotherapy System (Galil Medical) under image guidance. Procedures are performed within the Advanced Multimodality Image Guided Operating (AMIGO) Suite, which allows high precision by keeping the patient stationary while imaging is done. This approach aims to reduce procedure time and avoid injury to nearby tissues. The study evaluates the effects of this cryotherapy on nerves and facet joints causing pain in the head, neck, and spine. Participants will undergo pre- and post-procedure imaging and follow-up visits to assess pain relief. The main outcome measured is the elimination of radicular pain or pain due to spinal disease within one month, with secondary measures tracking longer-term relief over one year. Researchers will monitor participants’ pain levels and overall response to the treatment, ensuring safety and adherence throughout the study period.
CONDITIONS
Brief Title
MRI-Guided Cryoablation to Alleviate Pain in Head, Neck and Spine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 suitable for a minimally invasive image-guided procedure.
- Participants must be able to attend all scheduled visits and imaging sessions.
- Participants must be at least 18 years old.
- Participants must have an estimated life expectancy greater than 8 weeks as determined by a clinician.
- Patients with radiculopathy must have pain confirmed by a nerve block within 3 months prior to ablation.
You will not qualify if you...
- Contraindications to MRI or gadolinium contrast, such as an estimated Glomerular Filtration Rate less than 60 ml/min or metal clips.
- Pregnant or breastfeeding women are excluded from this research.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants undergo MRI-guided cryoablation of nerves and facet joints to alleviate radicular pain or pain caused by spinal disease using the MRI Seednet Cryotherapy System.
1 procedure visit (in-person)
Duration - Up to 1 year
Participants are monitored for long-term relief of radicular pain and pain from spinal disease.
Follow-up visits as scheduled over 1 year
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
T
Thomas Lee, MD
D
Danielle Chamberlain, BS, RT(R)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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