Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Polyganics BV73 enrolled

Overview

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.

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, Poly(68/32\[15/85 D/L\] 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuroma

Interventions

Neurocap®DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Arizona Center for Hand Surgery

Phoenix, Arizona, United States

Stanford Medical Center Hand and Upper Limb Center

Redwood City, California, United States

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) for Pain

Subjective pain score as indicated by the patient on a scale of 1-100.

Time frame: 2 years

Secondary Outcomes

Recurrence of Neuroma

Recurrence of neuroma as assessed by clinical assessment by the surgeon.

Time frame: 2 years

Elliot Neuroma questionnaire

Type of pain

Time frame: 2 years

QuickDASH

Daily functioning upper limb

Time frame: 2 years

Goals questionnaire

Daily functioning lower limb

Time frame: 2 years

Type of Pain Medication

Type of pain medication currently taken

Time frame: 2 years

Amount of Pain Medication

Amount of pain medication currently taken

Time frame: 2 years

Data from ClinicalTrials.gov

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