Status:
COMPLETED
Patient Controlled Tissue Expansion for Breast Reconstruction
Lead Sponsor:
AirXpanders, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
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.
Detailed Description
This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently clea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 5\. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.
- 6\. 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).
- 7\. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).
- 8\. Subject is currently participating in a concurrent investigational drug or device study.
- 9\. 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.
- 12\. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- 13\. Subject is pregnant or planning on becoming pregnant during the study period.
- 14\. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01425268
Start Date
October 1 2011
End Date
August 1 2015
Last Update
June 27 2017
Active Locations (17)
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1
Marin General Hospital
Greenbrae, California, United States, 94904
2
Susan Downey
Los Angeles, California, United States, 90004
3
University of California, Irvine Medical Center
Orange, California, United States, 92868
4
Sutter Healthcare-Sacramento
Sacramento, California, United States, 95825