|By Marketwired .||
|September 5, 2013 06:17 PM EDT||
HOUSTON, TX -- (Marketwired) -- 09/05/13 -- Dr. Aldona J. Spiegel at the Center for Breast Restoration in Houston, Texas is enrolling mastectomy patients into a clinical study designed to evaluate a new tissue expansion method for those who choose to undergo breast reconstruction. Dr. Spiegel is the first in Texas to offer this randomized, controlled clinical study to directly compare the outcomes of the traditional saline tissue expansion method to an investigational, remote-controlled, needle-free, carbon dioxide-based tissue expansion system known as The AeroForm Patient Controlled Tissue Expander System.
Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a standard saline or silicone breast implant can be placed.
"Traditionally, women undergoing breast reconstruction have had to undergo a long process of inconvenient injections using conventional saline expanders to create a pocket for a standard implant following a mastectomy," said Dr. Spiegel, breast reconstruction surgeon. "This investigational system eliminates the need for saline injections by allowing the patient to trigger the release of small amounts of compressed carbon-dioxide through the valve of a tiny chamber located inside the expander."
The patient uses the remote control to gradually inflate the investigational expander in small, pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits.
Patients in the study will be randomly selected to receive the investigational expander or a traditional saline expander. The patients who receive the investigational expander will use a wireless remote control to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander. Once the patient's tissue is adequately expanded, the expander is removed and a standard implant placed during a surgical procedure.
A clinical study in Australia showed the average expansion time associated with the remote-controlled tissue expander was 17 days, a fraction of the time required using traditional expanders which can take months to achieve full expansion.
The current standard of care in tissue expansion involves implanting a saline expander under the skin and pectoral muscle following a mastectomy procedure. The patient returns to her doctor weekly for bolus saline injections which can take as long as four to five months.
Dr. Aldona Spiegel and other Reconstructive Surgeons at hospitals across the U.S. are participating in the study. Enrollment will continue until a total of 92 AeroForm expanders and 46 saline expanders have been implanted in patients. AeroForm will be evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a standard breast implant. Secondary measurements will include the average number of days needed to achieve the desired expansion, total reconstruction time, pain and patient satisfaction.
The AeroForm Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, CA. The U.S. Food and Drug Administration (FDA) has granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study and it has been approved for enrollment.
For more information on the study, please visit clinicaltrials.gov (NCT01425268).
If you or someone you know is interested in joining the study in Houston, please call Dr. Spiegel's office at 713-441-6102.
E-mail: [email protected]