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Cooled RF Lesion MRI Characteristics

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ClinicalTrials.gov Identifier: NCT03631030
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Halyard Health
Information provided by (Responsible Party):
International Spine, Pain and Performance Center

Brief Summary:
This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).

Condition or disease Intervention/treatment Phase
Arthritis;Lumbosacral Osteo Arthritis Knee Sacroiliitis Hip Osteoarthritis Arthritis, Degenerative Device: Cooled radiofrequency ablation Not Applicable

Detailed Description:

This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.

The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.

MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, singe group cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain
Actual Study Start Date : February 25, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cooled radiofrequency ablation
This is a single arm study. Patients who will be undergoing cooled radiofrequency ablation for the treatment of arthritis in the cervical facet joints, thoracic facet joints, lumbar facet joints, sacroiliac (SI) region, hip and knee.
Device: Cooled radiofrequency ablation
Cooled Radiofrequency ablation (CRFA) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures




Primary Outcome Measures :
  1. Cooled radiofrequency ablation lesion size [ Time Frame: MRI obtained between 2-7 days post-procedure. ]
    Size in millimeters of cooled radiofrequency ablation lesion via MRI


Secondary Outcome Measures :
  1. Pain relief [ Time Frame: 2-4 weeks post-procedure as compared to pre-procedure ]
    Compare pre-procedure and post-procedure change in pain using the numerical pain rating scale with 0 being no pain and 10 being the worst possible pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 21 years
  2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
  3. Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.
  4. Willing and able to receive an MRI

Exclusion Criteria:

  1. Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
  2. Unable to receive an MRI (i.e. iron-based metal implant).
  3. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.
  4. Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
  5. Subject currently implanted with a pacemaker or defibrillator
  6. In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment
  7. Subject unwillingness or unable to comply with protocol requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631030


Contacts
Contact: Puneet Sayal, MD, MPH 202-808-8295 drsayal@isppcenter.com
Contact: Mehul Desai, MD, MPH 202-808-8295 drdesai@isppcenter.com

Locations
United States, District of Columbia
International Spine, and Performance Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Mehul Desai, MD, MPH    202-808-8295    drdesai@isppcenter.com   
Contact: Puneet Sayal, MD, MPH    202-808-8295    drsayal@isppcenter.com   
Principal Investigator: Mehul Desai, MD, MPH         
Sub-Investigator: Puneet Sayal, MD, MPH         
United States, Virginia
International Spine, Pain and Performance Center Recruiting
Arlington, Virginia, United States, 22205
Contact: Puneet Sayal, MD, MPH    703-718-4282    drsayal@isppcenter.com   
Contact: Mehul Desai, MD, MPH    703-718-4282    drdesai@isppcenter.com   
Principal Investigator: Mehul Desai, MD, MPH         
Sub-Investigator: Puneet Sayal, MD, MPH         
Sponsors and Collaborators
International Spine, Pain and Performance Center
Halyard Health
Investigators
Principal Investigator: Mehul Desai, MD, MPH International Spine Pain & Performance Center
  Study Documents (Full-Text)

Documents provided by International Spine, Pain and Performance Center:
Study Protocol  [PDF] May 24, 2018
Informed Consent Form  [PDF] July 12, 2018


Publications:

Responsible Party: International Spine, Pain and Performance Center
ClinicalTrials.gov Identifier: NCT03631030     History of Changes
Other Study ID Numbers: 105-17-0004
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by International Spine, Pain and Performance Center:
Cooled radiofrequency ablation
MRI

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Sacroiliitis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases