Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"
France, Netherlands10 participantsStarted 2016-01
Plain-language summary
This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
. Subjects who are \> 18 years year old.
. Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
. Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
. Symptomatic neuroma confirmed by pain relief following a 10min ±2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as any reduction in VAS questionnaire score.
. Subjects with history of pain in the area of the end-neuroma for at least 6-months.
. Subjects with a positive Tinel's sign.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety data (Serious adverse events )
Timeframe: 6 weeks
2
Effectiveness (VAS score)
Timeframe: 6 weeks
3
Effectiveness (QuickDASH score)
Timeframe: 6 weeks
4
Effectiveness (Quantity and class of pain medication used)
. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
. Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation or subjects who are not using appropriate birth control.
. Subjects who have had historical radiotherapy in the area of the end-neuroma.
. Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
. Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
. Subjects is involved in another pain study.
. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32\[15/85 D/L\] Lactide-Ԑ-Caprolactone) (PLCL).
. Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.