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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05604144
Other study ID # IITMN001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 22, 2022
Est. completion date April 22, 2023

Study information

Verified date November 2022
Source Northern California Research Trials, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States NorthBay Healthcare Fairfield California
United States NorthBay Healthcare Vacaville California

Sponsors (3)

Lead Sponsor Collaborator
Northern California Research Trials, Inc. NorthBay Healthcare, Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Primary Pain Management 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 Adverse Events and Serious Adverse Events 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
Secondary Ambulation 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
Secondary Medical Device Feasibility Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to SOC treatment modalities. Six Months
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