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Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02993276
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Polyganics BV

Study Description
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Brief Summary:

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
Neuroma Device: Neurocap®

Detailed Description:
  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 Design
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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort Intervention/treatment
Treatment Group
All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) for Pain [ Time Frame: 2 years ]
    Subjective pain score as indicated by the patient on a scale of 1-100.


Secondary Outcome Measures :
  1. Recurrence of Neuroma [ Time Frame: 2 years ]
    Recurrence of neuroma as assessed by clinical assessment by the surgeon.

  2. Elliot Neuroma questionnaire [ Time Frame: 2 years ]
    Type of pain

  3. QuickDASH [ Time Frame: 2 years ]
    Daily functioning upper limb

  4. Goals questionnaire [ Time Frame: 2 years ]
    Daily functioning lower limb

  5. Type of Pain Medication [ Time Frame: 2 years ]
    Type of pain medication currently taken

  6. Amount of Pain Medication [ Time Frame: 2 years ]
    Amount of pain medication currently taken


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the neuroma.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Buncke Clinic
San Francisco, California, United States, 94114
United States, Oregon
Veterans affairs Medical Center Portland
Portland, Oregon, United States, 97239
United States, Pennsylvania
Geisinger Clinic
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
France
Clinique Chirurgicale Victor Hugo Paris
Paris, France
Germany
BG Trauma Center Frankfurt am Main GmbH
Frankfurt am Main, Germany, 60389
Italy
Ospedale San Guiseppe Milano
Milano, Italy
Spain
Parc Sanitari Sant Joan de Deu
Barcelona, Spain
Sweden
Sahlgrenska University Hospital Gothenburg
Goteborg, Sweden
University Hospital Linköping
Linkoping, Sweden
University Hospital Lund - Department of Hand Surgery
Malmo, Sweden
United Kingdom
Birmingham Hand Centre
Birmingham, United Kingdom
Sponsors and Collaborators
Polyganics BV
More Information
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Responsible Party: Polyganics BV
ClinicalTrials.gov Identifier: NCT02993276    
Other Study ID Numbers: CR-02
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
Additional relevant MeSH terms:
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Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms