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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT00943605
Eligibility Criteria:
Inclusion Criteria:
1. Age between 20 and 70 years old
2. Physically healthy, stable weight
3. Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy
4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure
5. Subject must be willing and able to comply with all follow-up evaluations
Exclusion Criteria:
1. Age younger than 20 or greater than 70 years old
2. Anticoagulation therapy which cannot be discontinued
3. Prior external beam or implanted radiotherapy
4. Tobacco use (any kind)
5. Infection (local or systemic)
6. Cognitive impairment or mental illness
7. Severe cardiopulmonary deficiencies
8. Known coagulopathy
9. Immunocompromised
10. Kidney disease (any type)
11. Desiring or requiring same-day breast reconstruction
12. Prior breast reduction or augmentation surgery
13. Unable to follow instructions or complete follow-up
14. Currently taking any medication known to affect healing
15. Subjects who are status-post gastric banding or gastric bypass
16. Currently enrolled in another investigational device or drug trial
17. Time from most recent neoadjuvant therapy less than 4 weeks
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT00943605
Study Brief:
Protocol Section:
NCT00943605