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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by AirXpanders, Inc.
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.
ClinicalTrials.gov Identifier:
NCT02504424
First received: July 20, 2015
Last updated: April 15, 2016
Last verified: April 2016
  Purpose
This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.

Condition Intervention
Breast Cancer
Device: AeroForm Tissue Expander

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND II)

Resource links provided by NLM:


Further study details as provided by AirXpanders, Inc.:

Primary Outcome Measures:
  • Successful tissue expansion with exchange to a permanent breast implant unless exchange is precluded by a non-device related event. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The primary endpoint will be analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction will be counted as failures.


Secondary Outcome Measures:
  • Device Safety (evaluated by the data collected on device related adverse events, serious device related adverse events, all adverse and serious adverse events) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 whether there is a causal relationship to the device), and device malfunctions leading to expander removal and/or replacement.


Estimated Enrollment: 60
Study Start Date: October 2015
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AeroForm Tissue Expander
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
Device: AeroForm Tissue Expander
The AeroForm 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.

Detailed Description:
This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is female between the ages of 18-70
  • Subject requires tissue expansion as part of breast reconstruction
  • Subject is able to provide written informed consent
  • Subject is able and willing to comply with all of the study requirements
  • Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen

Exclusion Criteria:

  • Subject's tissue integrity is unsuitable for tissue expansion
  • Subject has residual gross malignancy at the intended expansion site
  • Subject has current or prior infection at the intended expansion site
  • Subject has a history of failed tissue expansion or breast reconstruction
  • Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)
  • Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).
  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: NCT02504424

Contacts
Contact: Kathryn Kelley, R.N., B.S.N. 650-390-9003 kkelley@airxpanders.com
Contact: Shakeh Aloianmelikpour, M.S. 650-390-9013 Shakeh@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: Gina Osborne, R.N.    415-927-7660    gina@mohebaliplasticsurgery.com   
Principal Investigator: Khashayar Mohebali, M.D.         
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: Kamakshi Zeidler, M.D.         
Sub-Investigator: Larry Berkowitz, M.D.         
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Tracey Stokes, M.D.    954-533-1671    tstokesmd@bellsouth.net   
Contact: Laura Sudarsky, M.D.    (954) 533-1671    laurasudarskymd@gmail.com   
Principal Investigator: Tracey Stokes, M.D.         
Sub-Investigator: Laura Sudarsky, M.D.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Amy Colwell, M.D.    617-643-5963    acolwell@partners.org   
Contact: Francine Molay, MSW, LICSW    617-643-6184    fmolay@mgh.harvard.edu   
Principal Investigator: Amy Colwell, M.D.         
Faulkner Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: Yoon Chun, M.D.    617-983-4774    ychun@partners.org   
Contact: Gretchen Guldbrandsen    617-983-4774    gguldbrandsen@partners.org   
Principal Investigator: Yoon Chun, 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 Tessier    508-856-1729    heather.strom@umassmed.edu   
Principal Investigator: John Castle, M.D.         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032-3713
Contact: Jeffrey Ascherman, M.D.    212-305-9612    jaa7@columbia.edu   
Contact: Kerry Morrison, B.A.    212-305-9612    kam2188@columbia.edu   
Principal Investigator: Jeffrey Ascherman, MD         
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: Jasmine Summers, R.N.    704-347-2055    jssummers@novanthealth.org   
Principal Investigator: James Appel, M.D.         
Sponsors and Collaborators
AirXpanders, Inc.
Investigators
Study Chair: Daniel Jacobs, M.D. AirXpanders Chief Medical Officer
Principal Investigator: Jeffrey Ascherman, M.D. Columbia University
  More Information

Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT02504424     History of Changes
Other Study ID Numbers: CTP-0005 AirXpanders 
Study First Received: July 20, 2015
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by AirXpanders, Inc.:
Tissue Expansion
Tissue Expander
Breast Tissue Expansion
Breast Tissue Expander
Breast Reconstruction
2 Stage Breast Reconstruction

ClinicalTrials.gov processed this record on July 28, 2016