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

A Proof-of-Concept Study to Define the Safety, Efficacy and Feasibility of Cryoanalgesia (Iovera°®) 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.

Hypothesis: Cryoanalgesia (iovera°®) will provide a safe, effective and feasible tool as a pain medicine modality to offer analgesic pain relief in patients with Morton's Neuroma, thereby introducing a new non-opioid therapeutic option to these patients in need. Primary Objective: To define and characterize the analgesic effect following a single cryoanalgesic application to the Dorsal, Digital Proper Nerve/s in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies. Primary Endpoints: 1. The area under the curve of the Numeric Rating Scale (NRS) Pain Intensity Scores; the NRS is a 0 to 10 rating scale with the number "0" indicating "no pain" and the number "10" indicating the "worst possible pain". The NRS is completed by subjects three times per day from Day 0 to 3 months post treatment, then the NRS will be done weekly through 6 months post treatment. 2. The total daily opioid consumption will be evaluated from Day 0 to 6 months post treatment to determine if the cryoanalgesic treatment decreased the subject's daily opioid pain management requirement. Secondary Objectives: Safety: To define the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to treatment. Efficacy: To assess the cryoanalgesic application as defined by both the subject and physician; to define the impact of treatment related to ambulatory steps pre and post procedure. Feasibility: To characterize and compare the cryoanalgesic treatment process to Standard of Care (SOC) treatment modalities. Secondary Endpoints: Safety Endpoints: The incidence of treatment emergent AEs and SAEs will be recorded and evaluated from the date of the cryoanalgesic application through 6 months post treatment. Efficacy Endpoints: Ambulatory steps/distance will be recorded during the Screening Period and through 90 days post treatment. A wrist device will track the subjects daily steps (ambulation) before and after the cryoanalgesic treatment. Tracking the subject's daily steps before and after treatment may offer an objective measure of cryoanalgesic efficacy. Both Subject and Physician Satisfaction Questionnaires will be recorded from Day 0 post-treatment through the following 6 months. These standardized questionnaires describe how satisfied or unsatisfied the subjects and physician are from the cryoanalgesic treatment. Feasibility Endpoints: Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to Standard of Care treatment modalities.

As a Proof of Concept Study, 5 subjects will follow the same protocol, with one cryoanalgesic treatment (iovera°®) with a 6 month clinical follow-up.

iovera°® treatment will be administered via ultrasound guidance to 1-2 branches of the dorsal/digital/proper nerve/s that innervate the Morton's neuroma. The treatment will be completed one time per subject.

Numeric Rating Scale (NRS) Pain Intensity Scores completed by subjects three times per day from Day 0 to 3 months post treatment, then NRS weekly through 6 months post treatment. 2. The total daily opioid consumption from Day 0 to 6 months post treatment.

The incidence of treatment emergent AEs and SAEs will be recorded and evaluated from the date of the treatment through 6 months post treatment.

Ambulatory steps/distance will be recorded during the Screening Period and through 90 days post treatment. Both Subject and Physician Satisfaction Questionnaires will be recorded from Day 0 post-treatment through the following 6 months.

Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to SOC treatment modalities.

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.

Cleveland Clinic Communication: Morton's Neuroma: Causes, Symptoms, Diagnois & Treatment. https://my.cleveland clinic.org/health/diseases/15118-mortons-neuroma pages 1-13.

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