Clinical trial NCT02528266: Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"
Official title: Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroma
Lead sponsor: Polyganics BV
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety data (Serious adverse events )
timeFrame: 6 weeks
measure: Effectiveness (VAS score)
timeFrame: 6 weeks
measure: Effectiveness (QuickDASH score)
timeFrame: 6 weeks
measure: Effectiveness (Quantity and class of pain medication used)
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety (Rate of serious adverse device effects)
timeFrame: 3, 6 and 12 months
measure: Effectiveness (VAS score)
timeFrame: 3, 6, 12 months
measure: Effectiveness (QuickDASH score)
timeFrame: 3, 6, 12 months
measure: Effectiveness (DN4 score)
timeFrame: 6 weeks, 3, 6, 12 months
measure: Effectiveness (Elliot score)
timeFrame: 6 weeks, 3, 6, 12 months
measure: Effectiveness (Quantity and class of pain medication used)
timeFrame: 3, 6, 12 months
measure: Rate of recurrence of symptomatic neuroma
timeFrame: 12 months
Other outcomes:
measure: Usability (User Device Handling Questionnaire)
timeFrame: Day 0
Locations:
city: Strasbourg
country: France
facility: Strasbourg University Hospitals
city: Den Haag
country: Netherlands
facility: Haga Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Groningen
country: Netherlands
facility: UMCG
city: Groningen
country: Netherlands
facility: Martini Hospital Groningen
city: Lelystad
country: Netherlands
facility: MC Groep
city: Maastricht
country: Netherlands
facility: MUMC
Study officials:
affiliation: Polyganics BV
name: Betty IJmker, MSc
role: STUDY_CHAIR
References: