Breast Cancer Clinical Trial
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.
This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).
Subject is female between the ages of 18-70
Subject requires tissue expansion as part of breast reconstruction
Subject is able to provide written informed consent
Subject is able and willing to comply with all of the study requirements
Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen
Subject's tissue integrity is unsuitable for tissue expansion
Subject has residual gross malignancy at the intended expansion site
Subject has current or prior infection at the intended expansion site
Subject has a history of failed tissue expansion or breast reconstruction
Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)
Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 8 Locations for this study
Greenbrae California, 94904, United States
San Jose California, 95008, United States
Fort Lauderdale Florida, 33316, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02130, United States
Worcester Massachusetts, 01605, United States
New York New York, 10032, United States
Charlotte North Carolina, 28207, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.