CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 86 enrolled
Drug / intervention
AxoGuard® Nerve Cap +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03940963
NCT03940963N/ACompleted
CompareCT.gov

A Multicenter, Prospective, Randomized and Subject Blinded Comparative Study of AxoGuard® Nerve Cap and Neurectomy for the Treatment of Symptomatic Neuroma and Prevention of Recurrent End-Neuroma Pain

Axogen Corporation·interventional·Posted May 7, 2019·Updated Jan 9, 2025

In Brief

A clinical study evaluating AxoGuard® Nerve Cap and Standard Neurectomy for Symptomatic Neuroma and 2 related conditions. Completed, enrolled 86 participants across 11 sites.

Detailed Summary

Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or ankle. Study consists of 86 subjects randomized between the treatment groups followed for 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 7, 2019
Enrollment StartOct 10, 2018
Primary CompletionJul 17, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.2 years ago

Interventions

AxoGuard® Nerve Capdevice

Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma

Standard Neurectomyprocedure

Surgical excision of symptomatic neuroma