Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803149
Status:
UNKNOWN
Last Update Posted:
2022-06-30
First Post:
2021-03-12
Brief Title:
Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain
Sponsor:
Avanos Medical
Organization:
Avanos Medical
Study Overview
Official Title:
A Prospective Multi-center Randomized Single-Blind Clinical Trial Comparing COOLIEF Cooled Radiofrequency to Conventional Radiofrequency Ablation of the Medial Branch Nerves in the Management of Chronic Facetogenic Low Back Pain
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lumbar CvS
Brief Summary:
This study is being conducted to assess the relative effectiveness of radiofrequency neurotomy in subjects with chronic axial low back pain originating in the lumbar facet joints using the COOLIEF Cooled Radiofrequency Probe as compared to the same procedure conducted using a Standard Radiofrequency Probe
Detailed Description:
This is a prospective multi-center randomized single-blind comparison study examining the outcomes of subjects with chronic axial low back pain that originates in the lumbar facet joints undergoing a procedure to create a radiofrequency lesion in the medial branch nerves with either Cooled Radiofrequency Ablation CRFA or Conventional Standard Radiofrequency Ablation SRFA Approximately 188 participants from approximately 15 sites will be enrolled into this study with subjects undergoing either CRFA or SRFA in a 11 randomization scheme Follow-up will be conducted for 12 months post-treatment with the primary endpoint being completed at month 6 Pain overall outcome quality of life pain medication use and adverse events will be compared between the two treatment groups to determine success
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None