Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT02528266
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02528266
Study Brief:
Protocol Section:
NCT02528266