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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.

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 22, 2015
Results First Submitted Date  ICMJE August 8, 2018
Results First Posted Date  ICMJE September 5, 2018
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE November 12, 2015
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
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 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
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 ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
Official Title  ICMJE AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: AeroForm Tissue Expander
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
Intervention: Device: AeroForm Tissue Expander
Publications * Ascherman JA, Zeidler K, Morrison KA, Appel J, Castle J, Chun Y, Colwell A, Mohebali K, Stokes T, Sudarsky L. Results of XPAND II: A Multicenter, Prospective, Continued-Access Clinical Trial Using the AeroForm Tissue Expander for Two-Stage Breast Reconstruction. Plast Reconstr Surg. 2020 Jan;145(1):21e-29e. doi: 10.1097/PRS.0000000000006395.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
60
Actual Study Completion Date  ICMJE September 26, 2017
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02504424
Other Study ID Numbers  ICMJE CTP-0005 AirXpanders
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AirXpanders, Inc.
Study Sponsor  ICMJE AirXpanders, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Daniel Jacobs, M.D. AirXpanders Chief Medical Officer
Principal Investigator: Jeffrey Ascherman, M.D. Columbia University
PRS Account AirXpanders, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP