Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"

Polyganics

Status: Completed

Conditions: Neuroma

Treatments: Device: Nerve Capping Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02528266

034A01_CIP

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects will be eligible according to the following criteria:

1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Subjects who are > 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.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from participation:

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-Ԑ-Caprolactone) (PLCL).
8. Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
9. Insufficient soft tissue at the end-neuroma site to cover the investigational device.
10. Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Nerve Capping Device

Experimental group

Description:

Implant with the experimental device

Treatment:

Device: Nerve Capping Device