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:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT01433302
Eligibility Criteria:
Inclusion Criteria:
1. Patients undergoing lymphatico-venular bypass for lymphedema.
2. History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.
3. A minimum of three (3) months post-op from any surgical interventions.
4. A minimum of six (6) months from the last dose of chemotherapy.
5. Patients with unilateral lymphedema.
Exclusion Criteria:
1. Active systemic infection or allergic reaction.
2. Active parasitic infection.
3. History of primary (congenital) lymphedema.
4. Metastatic cancer.
5. History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.
6. History of other fibroproliferative disorders including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.
7. Current treatment with steroids.
8. Concurrent secondary systemic cancer exclusive of cutaneous malignancies.
9. Treatment with myelosuppressive or stimulatory drugs within six (6) months of enrollment.
10. History of bone marrow transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01433302
Study Brief:
Protocol Section:
NCT01433302