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Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

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ClinicalTrials.gov Identifier: NCT02528266
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Polyganics BV

Tracking Information
First Submitted Date  ICMJE August 13, 2015
First Posted Date  ICMJE August 19, 2015
Last Update Posted Date June 13, 2018
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • Safety data (Serious adverse events ) [ Time Frame: 6 weeks ]
    Serious adverse events related to the investigation device as determine by independent expert.
  • Effectiveness (VAS score) [ Time Frame: 6 weeks ]
    Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) at 6-week follow-up compared to score at baseline.
  • Effectiveness (QuickDASH score) [ Time Frame: 6 weeks ]
    Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) at 6-week follow-up compared to score at baseline.
  • Effectiveness (Quantity and class of pain medication used) [ Time Frame: 6 weeks ]
    Quantity and class of pain medication used for the end-neuroma pain at 6-week follow-up compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
  • Safety (Rate of serious adverse device effects) [ Time Frame: 3, 6 and 12 months ]
    Rate of serious adverse device effects as determined by the physician and independent expert.
    • Reduction of pain caused by symptomatic neuroma after 3 months, 6 months and 12 months following the procedure, as compared to pain before the procedure.
    • Improvement of quality of life at 3 months, 6 months and 12 months follow-up, as compared to the quality of life before the procedure.
    • ≤20% recurrence of symptomatic neuroma within 12 months.
    • Reduction of pain medication used to treat neuroma pain at 3 months, 6 months and 12 months, as compared to the quantity pain medication used for the neuroma pain before the procedure.
  • Effectiveness (VAS score) [ Time Frame: 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) compared to score at baseline.
  • Effectiveness (QuickDASH score) [ Time Frame: 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) compared to score at baseline.
  • Effectiveness (DN4 score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: DN4 score (10 y/n items characterising pain) compared to score at baseline.
  • Effectiveness (Elliot score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: Elliot score (5 items rated 0 (no pain) to 4 (pain intolerable)) compared to score at baseline.
  • Effectiveness (Quantity and class of pain medication used) [ Time Frame: 3, 6, 12 months ]
    Quantity and class of pain medication used for the neuroma pain at 3, 6 and 12 months
  • Rate of recurrence of symptomatic neuroma [ Time Frame: 12 months ]
    defined as daily pain combined with increased used of pain medication compared to baseline and no improvement in QuickDASH score, but pain is relieved with Xylocaine nerve block.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • Safety (Rate of serious adverse device effects) [ Time Frame: 3, 6 and 12 months ]
    Rate of serious adverse device effects as determined by the physician and independent expert.
    • Reduction of pain caused by symptomatic neuroma after 3 months, 6 months and 12 months following the procedure, as compared to pain before the procedure.
    • Improvement of quality of life at 3 months, 6 months and 12 months follow-up, as compared to the quality of life before the procedure.
    • ≤20% recurrence of symptomatic neuroma within 12 months.
    • Reduction of pain medication used to treat neuroma pain at 3 months, 6 months and 12 months, as compared to the quantity pain medication used for the neuroma pain before the procedure.
  • Performance (VAS score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) compared to score at baseline.
  • Performance (QuickDASH score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) compared to score at baseline.
  • Performance (DN4 score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: DN4 score (10 y/n items characterising pain) compared to score at baseline.
  • Performance (Elliot score) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Pain caused by symptomatic end-neuroma: Elliot score (5 items rated 0 (no pain) to 4 (pain intolerable)) compared to score at baseline.
  • Performance (Quantity and class of pain medication used) [ Time Frame: 6 weeks, 3, 6, 12 months ]
    Quantity and class of pain medication used to treat neuroma pain compared to quantity and class of pain medication at baseline.
  • Rate of recurrence of symptomatic neuroma [ Time Frame: 12 months ]
    defined as daily pain combined with increased used of pain medication compared to baseline and no improvement in QuickDASH score, but pain is relieved with Xylocaine nerve block.
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2015)
Usability (User Device Handling Questionnaire) [ Time Frame: Day 0 ]
Ease of placement of the device assessed via User Device Handling Questionnaire.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"
Official Title  ICMJE Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
Brief Summary This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroma
Intervention  ICMJE Device: Nerve Capping Device
Study Arms  ICMJE Experimental: Nerve Capping Device
Implant with the experimental device
Intervention: Device: Nerve Capping Device
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2015)
21
Actual Study Completion Date  ICMJE March 30, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects will be eligible according to the following criteria:

  1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
  2. Subjects who are > 18 years year old.
  3. Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
  4. Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
  5. Symptomatic neuroma confirmed by pain relief following a 10min ±2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as any reduction in VAS questionnaire score.
  6. Subjects with history of pain in the area of the end-neuroma for at least 6-months.
  7. Subjects with a positive Tinel's sign.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation:

  1. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
  2. Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation or subjects who are not using appropriate birth control.
  3. Subjects who have had historical radiotherapy in the area of the end-neuroma.
  4. Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
  5. Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
  6. Subjects is involved in another pain study.
  7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
  8. Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
  9. Insufficient soft tissue at the end-neuroma site to cover the investigational device.
  10. Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02528266
Other Study ID Numbers  ICMJE 034A01_CIP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Polyganics BV
Study Sponsor  ICMJE Polyganics BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Betty IJmker, MSc Polyganics BV
PRS Account Polyganics BV
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP