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Compare Ultrasound Assisted Cold Therapy and Lidocaine Injection to Treat Morton's Neuroma

NCT02838758 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of a device that delivers freezing temperature compared to injecting lidocaine (an anesthetic medication) in providing pain relief to patients with disorganized nerve bundle between the toes, also known as Morton's neuroma. The same ultrasound technology that the obstetricians use to visualize a fetus inside a pregnant woman will be used to help the study physician to locate the Morton's neuroma while precisely delivering the freezing temperature and lidocaine near the nerve.

Conditions

  • Intermetatarsal Neuroma

Interventions

DEVICE

Cryoablation

A minimally invasive cryoablation device. It delivers focused nitrous oxide to the target tissue via a 22-gauge needle to create an approximately 9.4mm by 5.4mm spherical freezing zone of temperature between -20 to -100° C.

DRUG

Lidocaine

Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.

DRUG

Saline

Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.

Sponsors & Collaborators

Principal Investigators

  • David Spinner, DO · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02838758 on ClinicalTrials.gov