Patient Controlled Tissue Expansion for Breast Reconstruction

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.

Key facts

Study ID

NCT01425268

Run by

AirXpanders, Inc.

People needed

158

Starts

2011-10-01

Expected to finish

2015-08-01

Last updated by the study team

2017-06-27

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subject is a woman between the ages of 18-70.
• Subject needs to have tissue expansion as part of her breast reconstruction.
• Subject is able to provide written informed consent.
• Subject is able and willing to comply with all of the study requirements.
• Subject is able to understand and manage at home dosing regimen.

You may not qualify if…

• Subjects skin is not suitable for tissue expansion.
• Subject has remaining tumor cells following her mastectomy.
• Subject has a current or prior infection at the intended expansion site.
• Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.
• 4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.
• Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.
• Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).
• Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).
• Subject is currently participating in a concurrent investigational drug or device study.
• Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.
• Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
• Subject is pregnant or planning on becoming pregnant during the study period.
• Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

Where it is running

• Marin General Hospital — Greenbrae, California, United States
• Susan Downey — Los Angeles, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Sutter Healthcare-Sacramento — Sacramento, California, United States
• Good Samaritan Hospital, San Jose — San Jose, California, United States
• eSSe Plastic Surgery — Fort Lauderdale, Florida, United States
• Baptist Medical Center South — Jacksonville, Florida, United States
• Norton Healthcare Pavilion — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Faulkner Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Columbia University — New York, New York, United States
• South Nassau Communities Hospital — Oceanside, New York, United States
• Novant Health Presbyterian Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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