Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma (NCT05604144) | Clinical Trial Compass
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Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma
United States5 participantsStarted 2022-08-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.