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

November 17, 2022 updated by: Northern California Research Trials, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fairfield, California, United States, 94534
        • NorthBay Healthcare
      • Vacaville, California, United States, 95687
        • NorthBay Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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°®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Management
Time Frame: 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.
Six Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events and Serious Adverse Events
Time Frame: 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.
Six Months
Ambulation
Time Frame: 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.
Six Months
Medical Device Feasibility
Time Frame: Six Months
Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to SOC treatment modalities.
Six Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern California Research Trials, Inc.

Collaborators

Pacira Pharmaceuticals, Inc
NorthBay Healthcare

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2022

Primary Completion (Anticipated)

April 22, 2023

Study Completion (Anticipated)

April 22, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IITMN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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