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Cryoneurolysis vs Radiofrequency Ablation for Chronic Sacroiliac Joint Pain

NCT06935539 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-20

No results posted yet for this study

Summary

This is a single-center, randomized, open-label, pilot study in adult subjects with chronic sacroiliac joint (SIJ) pain. Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive ioveraº cryoneurolysis or radiofrequency ablation.

Conditions

  • Chronic Sacroiliac Joint Pain

Interventions

DEVICE

Cryoneurolysis

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 "STT21180STIM" Smart Tip will be used in this study.

DEVICE

Radiofrequency ablation

Radiofrequency ablation is a minimally invasive procedure that uses heat at the lumbosacral spine to destroy the target spinal nerves.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Medical Pain Management Services, PLLC

    lead OTHER

Principal Investigators

  • Martin Ferrillo, DO · The Albany & Saratoga Centers For Pain Management

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-07-31
Completion
2026-08-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935539 on ClinicalTrials.gov