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Study of AeroForm Tissue Expander for Breast Reconstruction (ASPIRE)

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: NCT01903174
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.

Tracking Information
First Submitted Date  ICMJE July 16, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
Adverse Events related to the Breast Reconstruction Procedure [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of AeroForm Tissue Expander for Breast Reconstruction
Official Title  ICMJE AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
Brief Summary This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
Detailed Description The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria
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
  • Breast Reconstruction
Intervention  ICMJE Device: AeroForm Breast Tissue Expander
Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
Other Names:
  • AeroForm
  • AeroForm Tissue Expander
  • AirXpander
  • AirXpander Tissue Expander
  • AirXpanders Breast Tissue Expander
Study Arms  ICMJE Experimental: AeroForm Tissue Expansion
AeroForm Breast Tissue Expander placed after mastectomy
Intervention: Device: AeroForm Breast Tissue Expander
Publications * Not Provided

*   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: March 21, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2013)
30
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is female between the ages of 18 - 70.
  2. Subject has elected two stage breast reconstruction with tissue expanders.
  3. Subject's tissue is amenable to tissue expansion.
  4. Subject is able to provide written informed consent.
  5. Subject is able and willing to comply with all of the study requirements.
  6. Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen.

Exclusion Criteria:

  1. Subject has residual gross malignancy following mastectomy.
  2. Subject has a current infection at the intended expansion site.
  3. Subject has clinically significant radiation fibrosis at the expansion site.
  4. Subject has planned radiation at the intended expansion site during the time the expander is implanted.
  5. 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).
  6. Subject is currently participating in a concurrent investigational drug or device study.
  7. Subject is a current tobacco smoker.
  8. Subject is overweight with a BMI > 33.
  9. Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
  10. Subject is pregnant or planning to become pregnant during the study period.
  11. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903174
Other Study ID Numbers  ICMJE CTP-0004
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
Principal Investigator: Tony Connell, F.R.A.C.S. Mount Hospital
PRS Account AirXpanders, Inc.
Verification Date March 2014

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