Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Completed

Conditions studied: Neuroma

In brief

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.

Key facts

Study ID

NCT02993276

Run by

Polyganics BV

People needed

73

Starts

2017-04-17

Expected to finish

2020-08-30

Last updated by the study team

2020-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
• Subjects who are able to comply with the follow-up or other requirements.
• Subjects who are ≥ 18 years old.
• Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
• 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.
• Subjects that are indicated for surgery to treat symptomatic neuroma.

You may not qualify if…

• Subjects who do not complete the informed consent.
• Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
• Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
• Subjects with congenital neuropathy.
• 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.
• Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
• Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-ε-Caprolactone) (PLCL).
• Proximal nerve end > 8mm.
• Pregnancy.

Where it is running

• Arizona Center for Hand Surgery — Phoenix, Arizona, United States
• Stanford Medical Center Hand and Upper Limb Center — Redwood City, California, United States
• Buncke Clinic — San Francisco, California, United States
• Veterans affairs Medical Center Portland — Portland, Oregon, United States
• Geisinger Clinic — Danville, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital) — Philadelphia, Pennsylvania, United States
• Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
• Clinique Chirurgicale Victor Hugo Paris — Paris, France
• BG Trauma Center Frankfurt am Main GmbH — Frankfurt am Main, Germany
• Ospedale San Guiseppe Milano — Milan, Italy
• Parc Sanitari Sant Joan de Deu — Barcelona, Spain
• Sahlgrenska University Hospital Gothenburg — Gothenburg, Sweden
• University Hospital Linköping — Linköping, Sweden
• University Hospital Lund - Department of Hand Surgery — Malmö, Sweden
• Birmingham Hand Centre — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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