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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT05541250
Eligibility Criteria:
Inclusion Criteria:
1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
2. Between the ages of 18 and 65 at last birthday
Exclusion Criteria:
1. Persons unable to safely undergo an MRI;
2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
3. Persons with severe peripheral nerve injury gap length \> 10 cm;
4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
7. History of active substance abuse;
8. Persons allergic to gentamicin;
9. Persons who test positive for HIV or Hepatitis B or C virus.
10. Persons unable to provide consent independently due to cognitive impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05541250
Study Brief:
Protocol Section:
NCT05541250