Clinical trial · Observational
Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
NCT02993276CI-TRIAL-00047082completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurocap® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment Group
- description
- All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.
- interventionNames
- Device: Neurocap®
Primary outcomes (1)
- measure
- Visual Analog Scale (VAS) for Pain
- timeFrame
- 2 years
- description
- Subjective pain score as indicated by the patient on a scale of 1-100.
Secondary outcomes (6)
- measure
- Recurrence of Neuroma
- timeFrame
- 2 years
- description
- Recurrence of neuroma as assessed by clinical assessment by the surgeon.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 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.
References
Publications (1)
- DERIVEDPower D, Curtin C, Bellemere P, Nyman E, Pajardi G, Isaacs J, Levin LS. Surgical Treatment of Symptomatic End-Neuroma With a New Bioresorbable Copolyester Nerve Capping Device: A Multicenter Prospective Cohort Study. Ann Plast Surg. 2023 Jul 1;91(1):109-116. doi: 10.1097/SAP.0000000000003596. PMID 37450869