NCT02528266

Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Polyganics BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.

Conditions

• Neuroma

Interventions

Type	Name	Description
DEVICE	Nerve Capping Device

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2015-08-19
• Last updated: 2018-06-13

Locations

7 sites across 2 countries: France, Netherlands