Neuroma Clinical Trial
Official title:
Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
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 |
Verified date | September 2019 |
Source | Polyganics BV |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Polyganics BV |
United States, France, Germany, Italy, Spain, Sweden, United Kingdom,
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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