Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Device: AeroForm Patient Controlled Tissue Expander Procedure: Implantation of Saline Tissue Expander |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction |
- Successful tissue expansion and exchange to a permanent breast implant unless precluded by a non-device related event [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary endpoint will be assessed when the subject has completed tissue expansion and had an exchange to permanent breast implants. Subjects not completing permanent breast implant procedure will be considered failures if the procedure could not be completed due to a device related event.
- The safety of the device will be evaluated by the data collected on device related adverse events, serious device related adverse events, all adverse and serious adverse events (regardless of their relationship to the device), and device malfunctions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]All adverse events will be collected and reported during the time that the expander is implanted. All events will be reported and categorized based on their relationship to the device or procedure. All device malfunctions will be reported.
| Estimated Enrollment: | 138 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Investigational (AeroForm Patient Controlled Tissue Expander)
The AeroForm Patient Controlled Tissue Expander is inflated with carbon dioxide using a remote control
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Device: AeroForm Patient Controlled Tissue Expander
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.
Other Names:
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Active Comparator: Saline Tissue Expander
A saline breast tissue expander is inflated by needle injections of saline
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Procedure: Implantation of Saline Tissue 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.
Other Names:
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Detailed Description:
This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Kathryn L Kelley, R.N., B.S.N. | 650-390-9003 | kkelley@airxpanders.com |
| Contact: Scott Dodson, B.S. | 650-390-9000 | sdodson@airxpanders.com |
| United States, California | |
| University of California, Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Gregory Evans, M.D. 714-456-3077 gevans@uci.edu | |
| Contact: Lavonnne Hart, R.N. 714-456-3077 lhart@uci.edu | |
| Principal Investigator: Gregory Evans, M.D. | |
| Sub-Investigator: Al Aly, M.D. | |
| Sub-Investigator: Garrett Wirth, M.D. | |
| Sub-Investigator: Keyian Paydar, M.D. | |
| Sutter Healthcare-Sacramento | Recruiting |
| Sacramento, California, United States, 95825 | |
| Contact: Debra Johnson, M.D. 916-929-1833 johnson@pscmail.com | |
| Contact: Lori Ried, R.N. 916-691-5976 RiedL@sutterhealth.org | |
| Principal Investigator: Debra Johnson, M.D. | |
| Sharp Healthcare - San Diego | Withdrawn |
| San Diego, California, United States, 91941 | |
| Good Samaritan Hospital, San Jose | Recruiting |
| San Jose, California, United States, 95008 | |
| Contact: Larry Berkowitz, M.D. 408-559-7177 rlb@rlberkowitzmd.com | |
| Contact: Kamakshi Zeidler, M.D. 408-559-7177 kamakshi.zeidler@gmail.com | |
| Principal Investigator: Larry Berkowitz, M.D. | |
| Sub-Investigator: Kamakshi Zeidler, M.D. | |
| United States, Florida | |
| Baptist Medical Center South | Recruiting |
| Jacksonville, Florida, United States, 32258 | |
| Contact: Ankit Desai, M.D. 904-262-3372 desaiplastics@gmail.com | |
| Contact: Heather Valentine, R.N. 904-880-9696 heather.valentine@eastcoastresearch.net | |
| Principal Investigator: Ankit Desai, M.D. | |
| Sub-Investigator: Michael Fallucco, M.D. | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Donald Morris, M.D. 617-383-6250 dmorris@lpsmd.com | |
| Contact: Jane April-Steinmetz 617-383-6250 japrilsteinmetz@lpsmd.com | |
| Principal Investigator: Donald Morris, M.D. | |
| Sub-Investigator: Terri Halperin, M.D. | |
| Faulkner Hospital | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Yoon Chun, M.D. 617-983-4774 ychun@partners.org | |
| Contact: Emma Sevigny 617-983-4774 esevigny@partners.org | |
| Principal Investigator: Yoon Chun, M.D. | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Amy Colwell, M.D. 617-643-5963 acolwell@partners.org | |
| Contact: Rita Hannah 617-643-5963 rhannah@partners.org | |
| Principal Investigator: Amy Colwell, M.D. | |
| University of Massachusetts Memorial Medical Center | Recruiting |
| Worcester, Massachusetts, United States, 01605 | |
| Contact: John Castle, M.D. 508-334-5591 john.castle@umassmemorial.org | |
| Contact: Ronald Ignotz, PhD 508-334-7692 ronald.ignotz@umassmed.edu | |
| Principal Investigator: John Castle, M.D. | |
| United States, Missouri | |
| Mercy Hospital, St. Louis | Withdrawn |
| Saint Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032-3713 | |
| Contact: Jeffrey Ascherman, MD 212-305-9612 jaa7@columbia.edu | |
| Contact: Jordan Ireton, B.S. 212-305-9612 Jei2107@Columbia.edu | |
| Principal Investigator: Jeffrey Ascherman, MD | |
| South Nassau Communities Hospital | Recruiting |
| Oceanside, New York, United States, 11572 | |
| Contact: Kaveh Alizadeh, M.D. 516-742-3404 kalizadeh@lipsg.com | |
| Contact: Shawna Moscowitz 516-535-6707 smoscowitz@lipsg.com | |
| Principal Investigator: Kaveh Alizadeh, M.D. | |
| Sub-Investigator: Noel Natoli, M.D. | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Scott Hollenbeck, M.D. 919-681-5079 scott.hollenbeck@duke.edu | |
| Contact: Jennifer Gallagher 919-970-1551 jennifer.gallagher@duke.edu | |
| Principal Investigator: Scott Hollenbeck, M.D. | |
| Sub-Investigator: Gregory Georgiade, M.D. | |
| Sub-Investigator: Michael Zenn, M.D. | |
| Principal Investigator: | Jeffrey A. Ascherman, M.D. | New York-Presbyterian Hospital / Columbia University |
More Information
Additional Information:
No publications provided
| Responsible Party: | AirXpanders, Inc. |
| ClinicalTrials.gov Identifier: | NCT01425268 History of Changes |
| Other Study ID Numbers: | CTP-0003 AirXpanders |
| Study First Received: | August 26, 2011 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AirXpanders, Inc.:
|
Tissue Expansion Tissue Expander Breast Tissue Expansion Breast Tissue Expander |
Breast Reconstruction Two Stage Breast Reconstruction 2 Stage Breast Reconstruction |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013