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 sectio

Phase 3

Completed

• Conditions: nerve fantom pain; symptomatic neuroma; 10034606

• Registration Number: NL-OMON43604
• Lead Sponsor: Polyganics BV, Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>- Rate of serious adverse device effects up to 6-week follow-up.<br /><br>Note: the relatedness of a SAE to the investigational device will be determined<br /><br>by an independent expert in addition to the investigators opinions.<br /><br><br /><br>Effectiveness:<br /><br>- Pain caused by symptomatic end-neuroma: VAS score at 6-week follow-up<br /><br>compared to score at baseline.<br /><br>- Quick DASH11 score at 6-week follow-up compared to score at baseline.<br /><br>- Quantity and class of pain medication used for the end-neuroma pain at 6-week<br /><br>follow-up compared to quantity and class of pain medication at baseline.</p><br>