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

NCT05604144 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-11-21

No results posted yet for this study

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.

Conditions

  • Morton's Neuroma
  • Pain Management

Interventions

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.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • NorthBay Healthcare

    collaborator OTHER

  • Northern California Research Trials, Inc.

    lead OTHER

Principal Investigators

  • Kevin M Miller, DPM, FACPM, FFPM · NorthBay Healthcare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2023-04-22
Completion
2023-04-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604144 on ClinicalTrials.gov