Trial Search Results

Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Polyganics BV

Stanford Investigator(s):

Intervention(s):

  • Device: Neurocap®

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting