30
Participants
Start Date
April 7, 2025
Primary Completion Date
May 31, 2026
Study Completion Date
May 31, 2026
iovera system
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.
Radiofrequency ablation alone
An electrode at the tip of the needle sends radio waves that lesion the nerve bundles.
University of Kansas Medical Center, Kansas City
University of Kansas Medical Center
OTHER