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Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

Primary Purpose

Neuroma

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Nerve Capping Device

About this trial

This is an interventional treatment trial for Neuroma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Strasbourg University Hospitals
Haga Hospital
Albert Schweitzer Hospital
UMCG
Martini Hospital Groningen
MC Groep
MUMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nerve Capping Device

Arm Description

Implant with the experimental device

Outcomes

Primary Outcome Measures

Safety data (Serious adverse events )

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

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.

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.

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

Secondary Outcome Measures

Safety (Rate of serious adverse device effects)

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)

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

Effectiveness (QuickDASH score)

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

Effectiveness (DN4 score)

Pain caused by symptomatic end-neuroma: DN4 score (10 y/n items characterising pain) compared to score at baseline.

Effectiveness (Elliot score)

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)

Quantity and class of pain medication used for the neuroma pain at 3, 6 and 12 months

Rate of recurrence of symptomatic neuroma

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.

Full Information

NCT ID

NCT02528266

First Posted

August 13, 2015

Last Updated

June 11, 2018

Sponsor

Polyganics BV

1. Study Identification

Unique Protocol Identification Number

NCT02528266

Brief Title

Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

March 30, 2018 (Actual)

Study Completion Date

March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polyganics BV

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nerve Capping Device

Arm Type

Experimental

Arm Description

Implant with the experimental device

Intervention Type

Device

Intervention Name(s)

Nerve Capping Device

Primary Outcome Measure Information:

Title

Safety data (Serious adverse events )

Description

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

Time Frame

6 weeks

Title

Effectiveness (VAS score)

Description

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

Time Frame

6 weeks

Title

Effectiveness (QuickDASH score)

Description

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

Time Frame

6 weeks

Title

Effectiveness (Quantity and class of pain medication used)

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Safety (Rate of serious adverse device effects)

Description

Time Frame

3, 6 and 12 months

Title

Effectiveness (VAS score)

Description

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

Time Frame

3, 6, 12 months

Title

Effectiveness (QuickDASH score)

Description

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

Time Frame

3, 6, 12 months

Title

Effectiveness (DN4 score)

Description

Pain caused by symptomatic end-neuroma: DN4 score (10 y/n items characterising pain) compared to score at baseline.

Time Frame

6 weeks, 3, 6, 12 months

Title

Effectiveness (Elliot score)

Description

Pain caused by symptomatic end-neuroma: Elliot score (5 items rated 0 (no pain) to 4 (pain intolerable)) compared to score at baseline.

Time Frame

6 weeks, 3, 6, 12 months

Title

Effectiveness (Quantity and class of pain medication used)

Description

Quantity and class of pain medication used for the neuroma pain at 3, 6 and 12 months

Time Frame

3, 6, 12 months

Title

Rate of recurrence of symptomatic neuroma

Description

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.

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Usability (User Device Handling Questionnaire)

Description

Ease of placement of the device assessed via User Device Handling Questionnaire.

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Betty IJmker, MSc

Organizational Affiliation

Polyganics BV

Official's Role

Study Chair

Facility Information:

Facility Name

Strasbourg University Hospitals

City

Strasbourg

ZIP/Postal Code

F-67493

Country

France

Facility Name

Haga Hospital

City

Den Haag

ZIP/Postal Code

2545 CH

Country

Netherlands

Facility Name

Albert Schweitzer Hospital

City

Dordrecht

ZIP/Postal Code

3318 AT

Country

Netherlands

Facility Name

UMCG

City

Groningen

ZIP/Postal Code

9713GZ

Country

Netherlands

Facility Name

Martini Hospital Groningen

City

Groningen

ZIP/Postal Code

9728 NT

Country

Netherlands

Facility Name

MC Groep

City

Lelystad

ZIP/Postal Code

8233AA

Country

Netherlands

Facility Name

MUMC

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

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