STOP NEUROMA Surgical Treatment Of symPtomatic NEUROMA: Open non-randomized clinical investigation to evaluate the safety and effectiveness of the nerve capping device to prevent neuroma formation after traumatic nerve section - STOP NEUROMA

Polyganics BV, Groningen0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
•2. Subjects who are > or <= 18 years year old.
•3. Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
•4. Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
•5. 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.
•6. Subjects with history of pain in the area of the end-neuroma for at least 6-months.
•7. Subjects with a positive Tinel*s sign.

•1. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
•2. 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.
•3. Subjects who have had historical radiotherapy in the area of the end-neuroma.
•4. Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
•5. Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
•6. Subjects is involved in another pain study.
•7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-*-Caprolactone) (PLCL).
•8. Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
•9. Insufficient amount of soft tissue to cover the investigational device.
•10. Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.

发起方

Polyganics BV, Groningen