CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
iovera system +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06016127
NCT06016127N/ACompleted
CompareCT.gov

A Single-center, Randomized, Pilot Study to Assess Iovera° Lumbar Medial Branch Cryoneurolysis vs Lumbar Radiofrequency Ablation for Facet Mediated Chronic Low Back Pain

Medical Pain Management Services, PLLC·interventional·Posted Aug 29, 2023·Updated Dec 6, 2024

In Brief

A clinical study evaluating iovera system and Radiofrequency ablation for Low Back Pain and Facet Joint Pain. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº medial branch cryoneurolysis or radiofrequency ablation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain, Facet Joint Pain
CountriesUnited States
CollaboratorsPacira Pharmaceuticals, Inc

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 29, 2023
Enrollment StartJun 18, 2022
Primary CompletionOct 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 2.8 years ago

Interventions

iovera systemdevice

The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip will be used in this study.

Radiofrequency ablationdevice

The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.