PROTECT NEURO
Research type
Research Study
Full title
PROSPECTIVE COHORT - EVALUATION OF NEUROCAP® - In the Treatment of symptomatic Neuroma
IRAS ID
220088
Contact name
Dominic Power
Contact email
Sponsor organisation
Polyganics Innovations BV
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
A neuroma is a disorganised overgrowth of nerve tissue that may occur following injury. Neuromas can be painful and patients frequently avoid contact with the painful area or any movement that irritates the nerve where it may be tethered in scar. When there is no nerve repair possible the neuroma is termed an “end neuroma” and surgical strategies are aimed at cushioning the affected area or burying the painful nerve end deeper in tissues away from the skin. The NEUROCAP® is a capping device that is placed over the cut end of a nerve after removal of the neuroma to protect it and prevent tether to the surrounding tissues. The cap device is slowly absorbed over approximately 2 years.
This study is designed to provide information regarding the outcome following surgical treatment of a neuroma with the Polyganics nerve capping device (NEUROCAP®). This data will be used for scientific publication and presentations at academic meetings. The data collected will include surgeon feedback, patient pain scores, outcomes and complications.
Subjects (≥ 18 years old) diagnosed with a peripheral symptomatic end neuroma in the upper or lower limb are eligible to participate in the study. Participants will be followed up for 24 months after the surgery with assessments at 3 months, 6 months, 12 months and 24 months. At these follow up time points patients will complete questionnaires and be asked about their pain, medications and any complications.This is an international study with recruitment of patients in both Europe and the USA. The study aims to recruit 92 patients over up to 20 centres.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0028
Date of REC Opinion
24 Feb 2017
REC opinion
Further Information Favourable Opinion