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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.

Cryoanalgesia (iovera°®)

Kevin M Miller, DPM, FACPM, FFPM

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:

1. Safety: To define the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to treatment.
2. 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.
3. Feasibility: To characterize and compare the cryoanalgesic treatment process to Standard of Care (SOC) treatment modalities.

Secondary Endpoints:

1. 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.
2. 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.
3. 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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma	NCT05604144	Morton's Neurom... Pain Management	Cryoanalgesia (...	18 Years -	Northern California Research Trials, Inc.
Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma	NCT05604144	Morton's Neurom... Pain Management	Cryoanalgesia (...	18 Years -	Northern California Research Trials, Inc.

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