AirXpanders AeroForm Tissue Expander System for Breast Reconstruction



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:1/31/2019
Start Date:November 12, 2015
End Date:September 26, 2017

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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)

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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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).
We found this trial at
8
sites
San Jose, California 95008
Principal Investigator: Kamakshi Zeidler, M.D.
Phone: 408-559-7177
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Amy Colwell, M.D.
Phone: 617-643-5963
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Boston, MA
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Jeffrey Ascherman, MD
Phone: 212-305-9612
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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Boston, Massachusetts 02133
Principal Investigator: Yoon Chun, M.D.
Phone: 617-983-4774
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Boston, MA
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Charlotte, North Carolina 28207
Principal Investigator: James Appel, M.D.
Phone: 704-444-5800
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Charlotte, NC
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Tracey Stokes, M.D.
Phone: 954-533-1671
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Lauderdale, FL
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Greenbrae, California 94904
Principal Investigator: Khashayar Mohebali, M.D.
Phone: 415-927-7660
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Greenbrae, CA
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Worcester, Massachusetts 01655
Principal Investigator: John Castle, M.D.
Phone: 508-334-5591
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Worcester, MA
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