NCT02993276

Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Polyganics BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neuroma

Interventions

Type	Name	Description
DEVICE	Neurocap®	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.

Timeline

• Start date: 2017-04-17
• Primary completion: 2018-07-06
• Completion: 2020-08-30
• First posted: 2016-12-15
• Last updated: 2020-09-10

Locations

16 sites across 7 countries: United States, France, Germany, Italy, Spain, Sweden, United Kingdom