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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02993276
Other study ID # CR-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2017
Est. completion date August 30, 2020

Study information

Verified date September 2019
Source Polyganics BV
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date August 30, 2020
Est. primary completion date July 6, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-e-Caprolactone) (PLCL).

8. Proximal nerve end > 8mm.

9. Pregnancy.

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
France Clinique Chirurgicale Victor Hugo Paris Paris
Germany BG Trauma Center Frankfurt am Main GmbH Frankfurt am Main
Italy Ospedale San Guiseppe Milano Milano
Spain Parc Sanitari Sant Joan de Deu Barcelona
Sweden Sahlgrenska University Hospital Gothenburg Goteborg
Sweden University Hospital Linköping Linkoping
Sweden University Hospital Lund - Department of Hand Surgery Malmo
United Kingdom Birmingham Hand Centre Birmingham
United States Geisinger Clinic Danville Pennsylvania
United States The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital) Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Center for Hand Surgery Phoenix Arizona
United States Veterans affairs Medical Center Portland Portland Oregon
United States Stanford Medical Center Hand and Upper Limb Center Redwood City California
United States Virginia Commonwealth University Medical Center Richmond Virginia
United States Buncke Clinic San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Polyganics BV

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) for Pain Subjective pain score as indicated by the patient on a scale of 1-100. 2 years
Secondary Recurrence of Neuroma Recurrence of neuroma as assessed by clinical assessment by the surgeon. 2 years
Secondary Elliot Neuroma questionnaire Type of pain 2 years
Secondary QuickDASH Daily functioning upper limb 2 years
Secondary Goals questionnaire Daily functioning lower limb 2 years
Secondary Type of Pain Medication Type of pain medication currently taken 2 years
Secondary Amount of Pain Medication Amount of pain medication currently taken 2 years
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