Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AirXpanders, Inc.
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.
ClinicalTrials.gov Identifier:
NCT01425268
First received: August 26, 2011
Last updated: July 25, 2014
Last verified: July 2014
  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 Tissue Expansion
Procedure: Saline Tissue Expansion
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

Resource links provided by NLM:


Further study details as provided by AirXpanders, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • AirXpander Tissue Expander System
  • Patient Activated Controlled Expansion (PACE)
  • AeroForm Patient Activated Tissue Expander
  • AeroForm Tissue Expander System
  • AeroForm Tissue 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.
Other Names:
  • saline breast tissue expander
  • saline expander
  • breast tissue expander
  • tissue expander

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
Criteria

Inclusion Criteria:

  1. Subject is a woman between the ages of 18-70.
  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:

  1. Subjects skin is not suitable for tissue expansion.
  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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425268

Contacts
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

Locations
United States, California
Marin General Hospital Recruiting
Greenbrae, California, United States, 94904
Contact: Khashayar Mohebali, M.D.    415-927-7660    kmohebali@yahoo.com   
Contact: Monica Sligh, R.N.    415-640-3209    msligh@kentfieldrehab.com   
Principal Investigator: Khashayar Mohebali, M.D.         
Susan Downey Recruiting
Los Angeles, California, United States, 90004
Contact: Susan Downey, M.D.    323-468-0127    sdowneymd@aol.com   
Contact: Irma Corral    323-468-0127    icseraphim@yahoo.com   
Principal Investigator: Susan Downey, M.D.         
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, RN    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 Completed
Jacksonville, Florida, United States, 32258
United States, Kentucky
Norton Healthcare Pavilion Completed
Louisville, Kentucky, United States, 40202
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: Natasha Isaac    617-724-4326    nisaac1@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: Heather Strom    508-856-1729    heather.strom@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: Adam Jacoby, B.S.    203-980-5245    aj2426@columbia.edu   
Principal Investigator: Jeffrey Ascherman, MD         
South Nassau Communities Hospital Completed
Oceanside, New York, United States, 11572
United States, North Carolina
Presbyterian Medical Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: James Appel, M.D.    704-444-5800    jappel@nova-health.org   
Contact: Maria Ghally, R.N.    704-347-2055    mwghally@novanthealth.org   
Principal Investigator: James Appel, M.D.         
Duke University Medical Center Completed
Durham, North Carolina, United States, 27705
United States, Texas
The Methodist Hospital Completed
Houston, Texas, United States, 77030
Sponsors and Collaborators
AirXpanders, Inc.
Investigators
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 25, 2014
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014