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

Sponsor
Northern California Research Trials, Inc. (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05604144
Collaborator
Pacira Pharmaceuticals, Inc (Industry), NorthBay Healthcare (Other)
5
Enrollment
2
Locations
1
Arm
8
Anticipated Duration (Months)
2.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cryoanalgesia (iovera°®)
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Proof-of-ConceptProof-of-Concept
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 22, 2022
Anticipated Primary Completion Date :
Apr 22, 2023
Anticipated Study Completion Date :
Apr 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Active Treatment

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.

Device: Cryoanalgesia (iovera°®)
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.
Other Names:
  • iovera°®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Management [Six Months]

      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.

    Secondary Outcome Measures

    1. Adverse Events and Serious Adverse Events [Six Months]

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

    2. Ambulation [Six Months]

      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.

    3. Medical Device Feasibility [Six Months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Healthy adult male or female volunteers ages 18 or older.

    2. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

    3. Body Mass Index (BMI) ≥18 and ≤40 kg/m2.

    4. Unilateral Morton's Neuroma diagnosed by MRI.

    5. Subject has failed conservative treatment options.

    Exclusion Criteria:

    1. Documented allergy, hypersensitivity, intolerance, or contraindication to amide-type local anesthetics (i.e., lidocaine), or opioids, NSAIDs.

    2. Documented history of uncontrolled diabetes, bleeding disorder, severe Peripheral Vascular Disease (PVD).

    3. 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.

    4. History of, suspected, or known addiction to/or abuse of illicit drug/s, prescription medicine/s, or alcohol within the past 3 years.

    5. Administration of an investigational drug or medical device within 30 days of the Screening Period.

    6. Previous participation in a cryoneurolysis study.

    7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Principal Investigator, could potentially interfere with study assessments or compliance.

    8. Currently pregnant, nursing, or planning to become pregnant during the study.

    9. Clinically significant medical disease that, in the opinion of the Principal Investigator, would make participation in a clinical study inappropriate.

    10. Inadequate sensory function of the affected foot (as defined at the Screening Visit Neurologic Lower Extremity (LE) exams).

    11. 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.

    12. Subject has a history of: Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria or Raynaud's Disease.

    13. Subject has an active, wound, open and/or potential infection near the anticipated treatment site.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NorthBay Healthcare Fairfield California United States 94534
    2 NorthBay Healthcare Vacaville California United States 95687

    Sponsors and Collaborators

    • Northern California Research Trials, Inc.
    • Pacira Pharmaceuticals, Inc
    • NorthBay Healthcare

    Investigators

    • Principal Investigator: Kevin M Miller, DPM, FACPM, FFPM, NorthBay Healthcare

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Northern California Research Trials, Inc.
    ClinicalTrials.gov Identifier:
    NCT05604144
    Other Study ID Numbers:
    • IITMN001
    First Posted:
    Nov 3, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Northern California Research Trials, Inc.
    Proof-of-Concept
    Pilot Study
    Podiatric Pain Management
    Cryoanalgesia
    Additional relevant MeSH terms:
    Neuroma
    Morton Neuroma

    Study Results

    No Results Posted as of Nov 21, 2022