CompletedNot Applicable

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 range18 Years

SexALL

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.

Exclusion criteria

✕. 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.

What they're measuring

Safety data (Serious adverse events )

Timeframe: 6 weeks

Effectiveness (VAS score)

Timeframe: 6 weeks

Effectiveness (QuickDASH score)

Timeframe: 6 weeks

Effectiveness (Quantity and class of pain medication used)

Timeframe: 6 weeks

Trial details

NCT IDNCT02528266

SponsorPolyganics BV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-30

View on ClinicalTrials.gov More Neuroma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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.

Exclusion criteria

✕. 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.