NCT01788410

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
48mo left

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
May 2013May 2030

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
17 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

17 years

First QC Date

February 7, 2013

Last Update Submit

August 7, 2023

Conditions

Facet Joints; DegenerationNeuropathyNeuralgia

Keywords

CryoablationNervesFacet jointPainNeuralgiaNeuropathyImage-guided

Outcome Measures

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.

    1 month

Secondary Outcomes (1)

  • Long term radicular pain relief

    1 year

Study Arms (1)

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).

Procedure: Cryoablation under image guidanceDevice: MRI Seednet Cryotherapy System (Galil Medical)

Interventions

Cryoablation under image guidancePROCEDURE

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

Also known as: MRI Seed Net Cryotherapy Unit (Galil Medical), Siemens IMRIS
Cryoablation under image guidance
MRI Seednet Cryotherapy System (Galil Medical)DEVICE

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

Also known as: FDA Approved, Cryoablation under image guidance
Cryoablation under image guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NeuralgiaPain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas C Lee, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Lee, MD

CONTACT

(617) 732-7260tchlee@partners.org

Danielle Chamberlain, BS, RT(R)

CONTACT

617-525-8596dchamberlain1@partners.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

May 1, 2013

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations

US(1)