XPAND II: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
A study for women who are undergoing breast reconstruction surgery using a new device called the AeroForm Tissue Expander System
Sponsor: AirXpanders
Enrolling: Male and Female Patients
IRB Number: AAAQ0212
U.S. Govt. ID: NCT02504424
Contact: Kerry Morrison: 000-000-0000 / kam2188@cumc.columbia.edu
Additional Study Information: The purpose of this study is to assess the performance and ease of use of the AeroDorm Tissue Expander System in women who are undergoing breast reconstruction surgery. This device is for use in women who are having or have had a mastectomy procedure to remove their breast(s) because of breast cancer (or to decrease their risk of breast cancer). The study will include women who plan to have immediate (at the same time as the mastectomy surgery) or delayed (sometime after the mastectomy surgery) breast reconstruction with placement of breast implants. This study will include women who need the skin and tissue of the chest wall stretched after their mastectomy surgery in order to create space to place a permanent breast implant(s). This stretching procedure is called tissue expansion and the investigational device is called a tissue expander. During this study you will have two surgeries, one to place the investigational tissue expander, then a few months later, a second surgery to remove the expander and place a permanent breast implant.
This study is closed
Jeffery Ascherman, MD
Do You Qualify?
Do you require tissue expansion as part of your breast reconstruction? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Kerry Morrison