Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

NCT02528266 | Completed DMC

• 1 other identifier: 034A01_CIP
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 7

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.

Conditions

Neuroma

Outcome Measures

Primary Outcomes (4)

• Safety data (Serious adverse events )

  Serious adverse events related to the investigation device as determine by independent expert.

  6 weeks

• Effectiveness (VAS score)

  Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) at 6-week follow-up compared to score at baseline.

  6 weeks

• Effectiveness (QuickDASH score)

  Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) at 6-week follow-up compared to score at baseline.

  6 weeks

• Effectiveness (Quantity and class of pain medication used)

  Quantity and class of pain medication used for the end-neuroma pain at 6-week follow-up compared to baseline

  6 weeks

Secondary Outcomes (7)

• Safety (Rate of serious adverse device effects)

  3, 6 and 12 months

• Effectiveness (VAS score)

  3, 6, 12 months

• Effectiveness (QuickDASH score)

  3, 6, 12 months

• Effectiveness (DN4 score)

  6 weeks, 3, 6, 12 months

• Effectiveness (Elliot score)

  6 weeks, 3, 6, 12 months

Other Outcomes (1)

• Usability (User Device Handling Questionnaire)

  Day 0

Study Arms (1)

Nerve Capping Device

EXPERIMENTAL

Implant with the experimental device

Device: Nerve Capping Device

Interventions

Nerve Capping Device DEVICE

Nerve Capping Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible according to the following criteria:
• Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
• Subjects who are \> 18 years year old.
• Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
• Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
• 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.
• Subjects with history of pain in the area of the end-neuroma for at least 6-months.
• Subjects with a positive Tinel's sign.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participation:
• Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
• 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.
• Subjects who have had historical radiotherapy in the area of the end-neuroma.
• Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
• Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
• Subjects is involved in another pain study.
• Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32\[15/85 D/L\] Lactide-Ԑ-Caprolactone) (PLCL).
• Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
• Insufficient soft tissue at the end-neuroma site to cover the investigational device.
• Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.

Sponsors & Collaborators

• Polyganics BV: lead

Study Sites (7)

Strasbourg University Hospitals

Strasbourg, F-67493, France

Location

Albert Schweitzer Hospital

Dordrecht, 3318 AT, Netherlands

Location

UMCG

Groningen, 9713GZ, Netherlands

Location

Martini Hospital Groningen

Groningen, 9728 NT, Netherlands

Location

MC Groep

Lelystad, 8233AA, Netherlands

Location

MUMC

Maastricht, 6229 HX, Netherlands

Location

Haga Hospital

The Hague, 2545 CH, Netherlands

Location

MeSH Terms

Conditions

Neuroma

Condition Hierarchy (Ancestors)

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

Study Officials

• Betty IJmker, MSc

  Polyganics BV

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 19, 2015
• Study Start: January 1, 2016
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

NL (6); FR (1)