Neuroma Clinical Trial
Official title:
Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT
Neuro)
This post-market surveillance study is conducted to provide post market surveillance
information regarding long-term performance and ease of use of the Polyganics nerve capping
device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
1. Device description NEUROCAP®, a bioresorbable nerve capping device based upon the
NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate
the nerve from surrounding environment to reduce the development of a symptomatic
neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester
composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone)
(PLCL).
2. Objective This post-market surveillance study is conducted to provide post market
surveillance information regarding long-term performance and ease of use of the
Polyganics nerve capping device (NEUROCAP®) for reduction of the development of
peripheral symptomatic end-neuroma.
3. Study design This post-market surveillance study consists of a cohort study to provide
post market surveillance information regarding long-term performance and ease of use of
the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in
the upper and lower extremity. Sub analyses will be performed regarding demographics and
medical background.
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