At a glance
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A 3-arm Randomized Controlled Study Comparing Ultrasound-guided Cryoablation, Ultrasound-guided Perineural Lidocaine and Ultrasound-guided Perineural Saline to Treat Intermetatarsal Neuroma
In Brief
A Phase 1 clinical trial evaluating Cryoablation, Lidocaine, and 1 other intervention for Intermetatarsal Neuroma. Completed, enrolled 10 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of a device that delivers freezing temperature compared to injecting lidocaine (an anesthetic medication) in providing pain relief to patients with disorganized nerve bundle between the toes, also known as Morton's neuroma. The same ultrasound technology that the obstetricians use to visualize a fetus inside a pregnant woman will be used to help the study physician to locate the Morton's neuroma while precisely delivering the freezing temperature and lidocaine near the nerve.
Study Details
Timeline
Interventions
A minimally invasive cryoablation device. It delivers focused nitrous oxide to the target tissue via a 22-gauge needle to create an approximately 9.4mm by 5.4mm spherical freezing zone of temperature between -20 to -100° C.
Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.
Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.