Breast Cancer, Breast Reconstruction
Conditions
Keywords
Breast Cancer, Breast Reconstruction, Breast Tissue Expansion, Breast Tissue Expander, Two Stage Breast Reconstruction
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 population with a broad selection criteria
Interventions
DEVICEAeroForm Breast Tissue Expander
Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
Sponsors
AirXpanders, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is female between the ages of 18 - 70. 2. Subject has elected two stage breast reconstruction with tissue expanders. 3. Subject's tissue is amenable to tissue expansion. 4. Subject is able to provide written informed consent. 5. Subject is able and willing to comply with all of the study requirements. 6. Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen.
Exclusion criteria
1. Subject has residual gross malignancy following mastectomy. 2. Subject has a current infection at the intended expansion site. 3. Subject has clinically significant radiation fibrosis at the expansion site. 4. Subject has planned radiation at the intended expansion site during the time the expander is implanted. 5. 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). 6. Subject is currently participating in a concurrent investigational drug or device study. 7. Subject is a current tobacco smoker. 8. Subject is overweight with a BMI \> 33. 9. Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device. 10. Subject is pregnant or planning to become pregnant during the study period. 11. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events related to the Breast Reconstruction Procedure | 6 months |
Countries
Australia
Outcome results
None listed