Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
NCT ID: NCT02993276
Last Updated: 2020-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
73 participants
OBSERVATIONAL
2017-04-17
2020-08-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment Group
All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.
Neurocap®
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.
Interventions
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Neurocap®
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 Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Polyganics BV
INDUSTRY
Responsible Party
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Locations
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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
Malmo, , Sweden
Birmingham Hand Centre
Birmingham, , United Kingdom
Countries
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References
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Power 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.
Other Identifiers
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CR-02
Identifier Type: -
Identifier Source: org_study_id
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