Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)
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|ClinicalTrials.gov Identifier: NCT01425268|
Recruitment Status : Completed
First Posted : August 30, 2011
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: AeroForm Tissue Expansion Procedure: Saline Tissue Expansion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: AeroForm Tissue Expansion
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
Device: 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.
Active Comparator: Saline Tissue Expansion
Saline Tissue Expansion inflated by needle injections of saline
Procedure: 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.
- Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event [ Time Frame: 12 months ]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.
- Expansion Days [ Time Frame: 12 months ]The median number of days taken to complete the expansion process.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425268
|Principal Investigator:||Jeffrey A. Ascherman, M.D.||New York-Presbyterian Hospital / Columbia University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||AirXpanders, Inc.|
|Other Study ID Numbers:||
|First Posted:||August 30, 2011 Key Record Dates|
|Results First Posted:||June 27, 2017|
|Last Update Posted:||June 27, 2017|
|Last Verified:||May 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Breast Tissue Expansion
Breast Tissue Expander
Two Stage Breast Reconstruction
2 Stage Breast Reconstruction