Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

NCT02993276 | Completed DMC

• 1 other identifier: CR-02
• Study Type: observational
• Target: 73
• Locations: 7 countries
• Sites: 16

Brief 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.

Conditions

Neuroma

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) for Pain

  Subjective pain score as indicated by the patient on a scale of 1-100.

  2 years

Secondary Outcomes (6)

• Recurrence of Neuroma

  2 years

• Elliot Neuroma questionnaire

  2 years

• QuickDASH

  2 years

• Goals questionnaire

  2 years

• Type of Pain Medication

  2 years

Study Arms (1)

Treatment Group

All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.

Device: Neurocap®

Interventions

Neurocap® DEVICE

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.

Treatment Group

Eligibility Criteria

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

Study Population

Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the neuroma.

You may qualify if:

• Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
• Subjects who are able to comply with the follow-up or other requirements.
• Subjects who are ≥ 18 years old.
• Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
• Subjects with a positive Tinel's sign.
• 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.
• Subjects that are indicated for surgery to treat symptomatic neuroma.

You may not qualify if:

• Subjects who do not complete the informed consent.
• Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
• Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
• Subjects with congenital neuropathy.
• 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.
• Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
• Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32\[15/85 D/L\] Lactide-ε-Caprolactone) (PLCL).
• Proximal nerve end \> 8mm.
• Pregnancy.

Sponsors & Collaborators

• Polyganics BV: lead

Study Sites (16)

Arizona Center for Hand Surgery

Phoenix, Arizona, 85004, United States

Location

Stanford Medical Center Hand and Upper Limb Center

Redwood City, California, 94063, United States

Location

Buncke Clinic

San Francisco, California, 94114, United States

Location

Veterans affairs Medical Center Portland

Portland, Oregon, 97239, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6061, United States

Location

The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)

Philadelphia, Pennsylvania, 19107, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

Location

Clinique Chirurgicale Victor Hugo Paris

Paris, France

Location

BG Trauma Center Frankfurt am Main GmbH

Frankfurt am Main, 60389, Germany

Location

Ospedale San Guiseppe Milano

Milan, Italy

Location

Parc Sanitari Sant Joan de Deu

Barcelona, Spain

Location

Sahlgrenska University Hospital Gothenburg

Gothenburg, Sweden

Location

University Hospital Linköping

Linköping, Sweden

Location

University Hospital Lund - Department of Hand Surgery

Malmo, Sweden

Location

Birmingham Hand Centre

Birmingham, United Kingdom

Location

Related Publications (1)

• Power D, Curtin C, Bellemere P, Nyman E, Pajardi G, Isaacs J, Levin LS. Surgical Treatment of Symptomatic End-Neuroma With a New Bioresorbable Copolyester Nerve Capping Device: A Multicenter Prospective Cohort Study. Ann Plast Surg. 2023 Jul 1;91(1):109-116. doi: 10.1097/SAP.0000000000003596.

  PMID: 37450869 DERIVED

MeSH Terms

Conditions

Neuroma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 15, 2016
• Study Start: April 17, 2017
• Primary Completion: July 6, 2018
• Study Completion: August 30, 2020
• Last Updated: September 10, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (8); DE (1); SE (3); GB (1); FR (1); IT (1)