Patient Controlled Tissue Expansion for Breast Reconstruction
XPAND
AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction
1 other identifier
interventional
158
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Oct 2011
Typical duration for not_applicable breast-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2011
CompletedFirst Posted
Study publicly available on registry
August 30, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
June 27, 2017
CompletedJune 27, 2017
May 1, 2017
3.8 years
August 26, 2011
February 26, 2017
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event
The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.
12 months
Secondary Outcomes (1)
Expansion Days
12 months
Study Arms (2)
AeroForm Tissue Expansion
EXPERIMENTALAeroForm Tissue Expansion inflation with carbon dioxide by remote control
Saline Tissue Expansion
ACTIVE COMPARATORSaline Tissue Expansion inflated by needle injections of saline
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.
- \. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.
- \. 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).
- \. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).
- \. Subject is currently participating in a concurrent investigational drug or device study.
- \. 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.
- \. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- \. Subject is pregnant or planning on becoming pregnant during the study period.
- \. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Marin General Hospital
Greenbrae, California, 94904, United States
Susan Downey
Los Angeles, California, 90004, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Sutter Healthcare-Sacramento
Sacramento, California, 95825, United States
Good Samaritan Hospital, San Jose
San Jose, California, 95008, United States
eSSe Plastic Surgery
Fort Lauderdale, Florida, 33308, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Norton Healthcare Pavilion
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Faulkner Hospital
Boston, Massachusetts, 02130, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605, United States
Columbia University
New York, New York, 10032-3713, United States
South Nassau Communities Hospital
Oceanside, New York, 11572, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28207, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 27879582BACKGROUNDZeidler 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.
PMID: 24740025DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Device improvements occurred during the study with later subjects completing the study with a revised version of the device. Results include all subjects treated in the study, regardless of device version.
Results Point of Contact
- Title
- Director of Clinical Affairs
- Organization
- AirXpanders
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A. Ascherman, M.D.
New York-Presbyterian Hospital / Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2011
First Posted
August 30, 2011
Study Start
October 1, 2011
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
June 27, 2017
Results First Posted
June 27, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share