Patient Controlled Tissue Expansion for Breast Reconstruction
NCT ID: NCT01425268
Last Updated: 2017-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2011-10-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AeroForm Tissue Expansion
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
AeroForm Tissue Expansion
The AeroForm Patient Controlled 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.
Saline Tissue Expansion
Saline Tissue Expansion inflated by needle injections of saline
Saline Tissue Expansion
A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Interventions
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AeroForm Tissue Expansion
The AeroForm Patient Controlled 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.
Saline Tissue Expansion
A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject needs to have tissue expansion as part of her breast reconstruction.
3. Subject is able to provide written informed consent.
4. Subject is able and willing to comply with all of the study requirements.
5. Subject is able to understand and manage at home dosing regimen.
Exclusion Criteria
2. Subject has remaining tumor cells following her mastectomy.
3. Subject has a current or prior infection at the intended expansion site.
4. 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.
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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Jeffrey A. Ascherman, M.D.
Role: PRINCIPAL_INVESTIGATOR
New York-Presbyterian Hospital / Columbia University
Locations
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Marin General Hospital
Greenbrae, California, United States
Susan Downey
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Sutter Healthcare-Sacramento
Sacramento, California, United States
Good Samaritan Hospital, San Jose
San Jose, California, United States
eSSe Plastic Surgery
Fort Lauderdale, Florida, United States
Baptist Medical Center South
Jacksonville, Florida, United States
Norton Healthcare Pavilion
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Faulkner Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Columbia University
New York, New York, United States
South Nassau Communities Hospital
Oceanside, New York, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Methodist Hospital
Houston, Texas, United States
Countries
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References
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Ascherman JA, Zeidler K, Morrison KA, Appel JZ, Berkowitz RL, Castle J, Colwell A, Chun Y, Johnson D, Mohebali K. Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial. Plast Reconstr Surg. 2016 Dec;138(6):1161-1170. doi: 10.1097/PRS.0000000000002784.
Zeidler KR, Berkowitz RL, Chun YS, Alizadeh K, Castle J, Colwell AS, Desai AR, Evans G, Hollenbeck S, Johnson DJ, Morris D, Ascherman JA. AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial. Ann Plast Surg. 2014 May;72 Suppl 1:S51-5. doi: 10.1097/SAP.0000000000000175.
Other Identifiers
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CTP-0003 AirXpanders
Identifier Type: -
Identifier Source: org_study_id
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