Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma (NCT02993276) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
United States73 participantsStarted 2017-04-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
âś“. Subjects who are able to comply with the follow-up or other requirements.
✓. Subjects who are ≥ 18 years old.
âś“. Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
âś“. Subjects with a positive Tinel's sign.
✓. Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS questionnaire score.
âś“. Subjects that are indicated for surgery to treat symptomatic neuroma.
Exclusion criteria
âś•. Subjects who do not complete the informed consent.
âś•. Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
âś•. Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
âś•. Subjects with congenital neuropathy.
âś•. Insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. Use of the device over a joint is advised against.