Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neuroma	Device: Nerve Capping Device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
• Actual Study Start Date: January 2016
• Actual Primary Completion Date: March 30, 2018
• Actual Study Completion Date: March 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nerve Capping Device; Implant with the experimental device	Device: Nerve Capping Device

Outcome Measures

Primary Outcome Measures :

1. Safety data (Serious adverse events ) [ Time Frame: 6 weeks ]
   Serious adverse events related to the investigation device as determine by independent expert.
2. 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.
3. 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.
4. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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
7. 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.

Other Outcome Measures:

1. Usability (User Device Handling Questionnaire) [ Time Frame: Day 0 ]
   Ease of placement of the device assessed via User Device Handling Questionnaire.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

France

Strasbourg University Hospitals

Strasbourg, France, F-67493

Netherlands

Haga Hospital

Den Haag, Netherlands, 2545 CH

Albert Schweitzer Hospital

Dordrecht, Netherlands, 3318 AT

UMCG

Groningen, Netherlands, 9713GZ

Martini Hospital Groningen

Groningen, Netherlands, 9728 NT

MC Groep

Lelystad, Netherlands, 8233AA

MUMC

Maastricht, Netherlands, 6229 HX

Sponsors and Collaborators

Polyganics BV

Investigators

• Study Chair: Betty IJmker, MSc; Polyganics BV

More Information

• Responsible Party: Polyganics BV
• ClinicalTrials.gov Identifier: NCT02528266
• Other Study ID Numbers: 034A01_CIP
• First Posted: August 19, 2015
• Last Update Posted: June 13, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms