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Trial record 1 of 1 for:    NCT02993276
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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
Sponsor:
Information provided by (Responsible Party):
Polyganics BV

Tracking Information
First Submitted Date December 8, 2016
First Posted Date December 15, 2016
Last Update Posted Date September 10, 2020
Actual Study Start Date April 17, 2017
Actual Primary Completion Date July 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2016)
Visual Analog Scale (VAS) for Pain [ Time Frame: 2 years ]
Subjective pain score as indicated by the patient on a scale of 1-100.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 12, 2016)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
Official Title Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the neuroma.
Condition Neuroma
Intervention 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.
Study Groups/Cohorts Treatment Group
All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.
Intervention: Device: Neurocap®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 27, 2018)
73
Original Estimated Enrollment
 (submitted: December 12, 2016)
92
Actual Study Completion Date August 30, 2020
Actual Primary Completion Date July 6, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Italy,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number NCT02993276
Other Study ID Numbers CR-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Polyganics BV
Study Sponsor Polyganics BV
Collaborators Not Provided
Investigators Not Provided
PRS Account Polyganics BV
Verification Date September 2019