Status:
COMPLETED
Study of AeroForm Tissue Expander for Breast Reconstruction
Lead Sponsor:
AirXpanders, Inc.
Conditions:
Breast Cancer
Breast Reconstruction
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
Detailed Description
The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient popu...
Eligibility Criteria
Inclusion
- Subject is female between the ages of 18 - 70.
- Subject has elected two stage breast reconstruction with tissue expanders.
- Subject's tissue is amenable to tissue expansion.
- 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.
Exclusion
- Subject has residual gross malignancy following mastectomy.
- Subject has a current infection at the intended expansion site.
- Subject has clinically significant radiation fibrosis at the expansion site.
- Subject has planned radiation at the intended expansion site during the time the expander is implanted.
- 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 currently participating in a concurrent investigational drug or device study.
- Subject is a current tobacco smoker.
- Subject is overweight with a BMI \> 33.
- Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- Subject is pregnant or planning to become 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.
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Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01903174
Start Date
June 1 2012
End Date
December 1 2013
Last Update
March 26 2014
Active Locations (1)
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1
Mount Hospital
Subiaco, Western Australia, Australia, 6008