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

Status unconfirmed · Not applicable

Conditions studied: Morton's Neuroma, Pain Management

In brief

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.

Key facts

Study ID

NCT05604144

Run by

Northern California Research Trials, Inc.

People needed

5

Starts

2022-08-22

Expected to finish

2023-04-22

Last updated by the study team

2022-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• NorthBay Healthcare — Fairfield, California, United States
• NorthBay Healthcare — Vacaville, California, United States

Full record on ClinicalTrials.gov

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