Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02993276
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2016-12-08
Brief Title:
Evaluation of NEUROCAP In the Treatment of Symptomatic Neuroma
Sponsor:
Polyganics BV
Organization:
Polyganics BV
Study Overview
Official Title:
Protect Neuro - Prospective Cohort Evaluation of NEUROCAP In the Treatment of Symptomatic Neuroma
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Poly68321585 DL 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None