Spots Global Cancer Trial Database for Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"
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Trial Identification
Brief Title: Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"
Official Title: Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
Study ID: NCT02528266
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Strasbourg University Hospitals, Strasbourg, , France
Haga Hospital, Den Haag, , Netherlands
Albert Schweitzer Hospital, Dordrecht, , Netherlands
UMCG, Groningen, , Netherlands
Martini Hospital Groningen, Groningen, , Netherlands
MC Groep, Lelystad, , Netherlands
MUMC, Maastricht, , Netherlands
Contact Details
Name: Betty IJmker, MSc
Affiliation: Polyganics BV
Role: STUDY_CHAIR
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