Spots Global Cancer Trial Database for Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
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Trial Identification
Brief Title: Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Official Title: Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Study ID: NCT02993276
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Center for Hand Surgery, Phoenix, Arizona, United States
Stanford Medical Center Hand and Upper Limb Center, Redwood City, California, United States
Buncke Clinic, San Francisco, California, United States
Veterans affairs Medical Center Portland, Portland, Oregon, United States
Geisinger Clinic, Danville, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital), Philadelphia, Pennsylvania, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Clinique Chirurgicale Victor Hugo Paris, Paris, , France
BG Trauma Center Frankfurt am Main GmbH, Frankfurt am Main, , Germany
Ospedale San Guiseppe Milano, Milano, , Italy
Parc Sanitari Sant Joan de Deu, Barcelona, , Spain
Sahlgrenska University Hospital Gothenburg, Goteborg, , Sweden
University Hospital Linköping, Linkoping, , Sweden
University Hospital Lund - Department of Hand Surgery, Malmo, , Sweden
Birmingham Hand Centre, Birmingham, , United Kingdom
Contact Details
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