Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Trial ID or NCT#
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.
Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
- 1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- 2. Subjects who are able to comply with the follow-up or other requirements.
- 3. Subjects who are ≥ 18 years old.
- 4. Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
- 5. Subjects with a positive Tinel's sign.
- 6. 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.
- 7. Subjects that are indicated for surgery to treat symptomatic neuroma.
- 1. Subjects who do not complete the informed consent.
- 2. Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
- 3. Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
- 4. Subjects with congenital neuropathy.
- 5. 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.
- 6. Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
- 7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-ε-Caprolactone) (PLCL).
- 8. Proximal nerve end > 8mm.
- 9. Pregnancy.
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