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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT01009008
Eligibility Criteria:
Inclusion Criteria:
1. Female between the ages of 18 and 65 years.
2. Planned breast reconstruction surgery post-mastectomy.
3. Able to provide informed consent.
4. Able to understand protocol components.
Exclusion Criteria:
1. Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e., infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration)
2. Residual gross tumor at the intended expansion site
3. History of or planned adjuvant radiation therapy
4. Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications.
5. Obesity with BMI of 30 or above
6. Current smoker
7. Psychologically unsuitable patient
8. Patient unable to understand the protocol for tissue expansion
9. Planned flight or assent to altitude exceeding 1000 meters above baseline during the expansion period.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01009008
Study Brief:
Protocol Section:
NCT01009008