CompletedNot Applicable

Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

United States, France, Germany73 participantsStarted 2017-04-17

Plain-language 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.

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 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.

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

Visual Analog Scale (VAS) for Pain

Timeframe: 2 years

Trial details

NCT IDNCT02993276

SponsorPolyganics BV

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-07-06

View on ClinicalTrials.gov More Neuroma trials

Plain-language summary

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 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.

Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria