AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
NCT ID: NCT02504424
Last Updated: 2019-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-11-12
2017-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AeroForm Tissue Expander
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expander
The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
Interventions
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AeroForm Tissue Expander
The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
70 Years
FEMALE
Yes
Sponsors
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AirXpanders, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Jacobs, M.D.
Role: STUDY_CHAIR
AirXpanders Chief Medical Officer
Jeffrey Ascherman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Marin General Hospital
Greenbrae, California, United States
Good Samaritan Hospital, San Jose
San Jose, California, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Faulkner Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Columbia University
New York, New York, United States
Presbyterian Medical Center
Charlotte, North Carolina, United States
Countries
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References
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Ascherman JA, Zeidler K, Morrison KA, Appel J, Castle J, Chun Y, Colwell A, Mohebali K, Stokes T, Sudarsky L. Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction. Plast Reconstr Surg. 2020 Jan;145(1):21e-29e. doi: 10.1097/PRS.0000000000006395.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CTP-0005 AirXpanders
Identifier Type: -
Identifier Source: org_study_id
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