Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma

This is a Proof-of-Concept Trial to define the safety, efficacy and feasibility of a cryoanalgesic device (iovera°®) for the treatment of pain in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.

Inclusion Criteria:Healthy adult male or female volunteers ages 18 or older.Able to provide informed consent, adhere to the study schedule, and complete all study assessments.Body Mass Index (BMI) ≥18 and ≤40 kg/m2.Unilateral Morton's Neuroma diagnosed by MRI.Subject has failed conservative treatment options.Exclusion Criteria:Documented allergy, hypersensitivity, intolerance, or contraindication to amide-type local anesthetics (i.e., lidocaine), or opioids, NSAIDs.Documented history of uncontrolled diabetes, bleeding disorder, severe Peripheral Vascular Disease (PVD).Concurrent painful physical condition that may require analgesic treatment (i.e., long-term opioid use) which, in the Principal Investigator's opinion, may confound the treatment assessments.History of, suspected, or known addiction to/or abuse of illicit drug/s, prescription medicine/s, or alcohol within the past 3 years.Administration of an investigational drug or medical device within 30 days of the Screening Period.Previous participation in a cryoneurolysis study.Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Principal Investigator, could potentially interfere with study assessments or compliance.Currently pregnant, nursing, or planning to become pregnant during the study.Clinically significant medical disease that, in the opinion of the Principal Investigator, would make participation in a clinical study inappropriate.Inadequate sensory function of the affected foot (as defined at the Screening Visit Neurologic Lower Extremity (LE) exams).Any clinically significant event or condition uncovered during the Screening Period (e.g., contra-lateral foot injury) that, in the opinion of the Principal Investigator, renders the subject medically unstable or complicates the subject's study participation.Subject has a history of: Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria or Raynaud's Disease.Subject has an active, wound, open and/or potential infection near the anticipated treatment site.