Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Neuroma Clinical Trial

Official title:

Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993276
• Other study ID #: CR-02
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Neuroma

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