Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
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|ClinicalTrials.gov Identifier: NCT02993276|
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : September 10, 2020
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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.
|Condition or disease||Intervention/treatment|
- 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).
- 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.
- 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|
|Actual Enrollment :||73 participants|
|Official Title:||Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma|
|Actual Study Start Date :||April 17, 2017|
|Actual Primary Completion Date :||July 6, 2018|
|Actual Study Completion Date :||August 30, 2020|
All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.
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.
- Visual Analog Scale (VAS) for Pain [ Time Frame: 2 years ]Subjective pain score as indicated by the patient on a scale of 1-100.
- Recurrence of Neuroma [ Time Frame: 2 years ]Recurrence of neuroma as assessed by clinical assessment by the surgeon.
- Elliot Neuroma questionnaire [ Time Frame: 2 years ]Type of pain
- QuickDASH [ Time Frame: 2 years ]Daily functioning upper limb
- Goals questionnaire [ Time Frame: 2 years ]Daily functioning lower limb
- Type of Pain Medication [ Time Frame: 2 years ]Type of pain medication currently taken
- Amount of Pain Medication [ Time Frame: 2 years ]Amount of pain medication currently taken
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993276
|United States, Arizona|
|Arizona Center for Hand Surgery|
|Phoenix, Arizona, United States, 85004|
|United States, California|
|Stanford Medical Center Hand and Upper Limb Center|
|Redwood City, California, United States, 94063|
|San Francisco, California, United States, 94114|
|United States, Oregon|
|Veterans affairs Medical Center Portland|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Danville, Pennsylvania, United States, 17822|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-6061|
|The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Virginia|
|Virginia Commonwealth University Medical Center|
|Richmond, Virginia, United States, 23219|
|Clinique Chirurgicale Victor Hugo Paris|
|BG Trauma Center Frankfurt am Main GmbH|
|Frankfurt am Main, Germany, 60389|
|Ospedale San Guiseppe Milano|
|Parc Sanitari Sant Joan de Deu|
|Sahlgrenska University Hospital Gothenburg|
|University Hospital Linköping|
|University Hospital Lund - Department of Hand Surgery|
|Birmingham Hand Centre|
|Birmingham, United Kingdom|
|Responsible Party:||Polyganics BV|
|Other Study ID Numbers:||
|First Posted:||December 15, 2016 Key Record Dates|
|Last Update Posted:||September 10, 2020|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type