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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02504424
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : September 5, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Device: AeroForm Tissue Expander Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)
Actual Study Start Date : November 12, 2015
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : September 26, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event [ Time Frame: 6 months ]
    The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.


Secondary Outcome Measures :
  1. Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort. [ Time Frame: 6 months ]
    Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in the analyses due to not completing the second stage surgery and withdrawal of consent.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

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): NCT02504424


Locations
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United States, California
Marin General Hospital
Greenbrae, California, United States, 94904
Good Samaritan Hospital, San Jose
San Jose, California, United States, 95008
United States, Florida
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Faulkner Hospital
Boston, Massachusetts, United States, 02130
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
United States, New York
Columbia University
New York, New York, United States, 10032-3713
United States, North Carolina
Presbyterian Medical Center
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
AirXpanders, Inc.
Investigators
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Study Chair: Daniel Jacobs, M.D. AirXpanders Chief Medical Officer
Principal Investigator: Jeffrey Ascherman, M.D. Columbia University
  Study Documents (Full-Text)

Documents provided by AirXpanders, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] June 30, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT02504424    
Other Study ID Numbers: CTP-0005 AirXpanders
First Posted: July 22, 2015    Key Record Dates
Results First Posted: September 5, 2018
Last Update Posted: January 29, 2019
Last Verified: January 2019
Keywords provided by AirXpanders, Inc.:
Tissue Expansion
Tissue Expander
Breast Tissue Expansion
 Breast Tissue Expander
Breast Reconstruction
2 Stage Breast Reconstruction