Clinical Trials

Are you considering breast reconstruction after a mastectomy?

Would you be interested in participating in a clinical research study using an investigational device for breast reconstruction?

XPAND II is a clinical study of the AeroForm® tissue expander, an investigational device used for breast reconstruction after mastectomy. During a mastectomy, breast tissue and skin are removed, and for many women, there will not be enough space for a breast implant. Thus, many women who elect to undergo breast reconstruction with breast implants will need to have a temporary tissue expander placed first to stretch the tissue and create space for the breast implant. Although there are many options for breast reconstruction, the tissue expander / breast implant procedure is the most common, accounting for over 60 percent of all breast reconstructions in the United States.

The current technique for tissue expansion involves a surgeon placing a temporary saline tissue expander under the skin and chest muscle. During weekly office visits, the surgeon inserts a needle through the skin and injects saline to fill the expander. As the device expands, the skin and tissue covering the expander stretches until there is enough space to place a breast implant. The expansion process can take several months to complete. Most surgeons will then wait up to two months before removing the expander and placing the breast implant.

The AeroForm tissue expander is a patient controlled tissue expander that is filled with carbon dioxide, a commonly used medical gas. Instead of injections of saline, the remote control is used to release gas to fill the expander. As the expander fills, the skin and tissue are gradually stretched similar to a saline expander and then replaced with a breast implant. This investigational device has been studied at centers across the USA, and has received approval in Europe and Australia.

Watch the following video to learn more about this patient controlled tissue expander:


To qualify for the XPAND II study, the participant must meet the following criteria:

  • Be between the ages 18-70;
  • Require tissue expansion as part of breast reconstruction;
  • Be able to provide informed written consent;
  • Be able and willing to comply with all the study requirements;
  • Be able to understand and manage the dosing regimen at home.

If you think you might be a good candidate for this study, visit II, NCT# 02504424),