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Study of AeroForm Tissue Expander for Breast Reconstruction (ASPIRE)

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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.

Brief Summary:
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Reconstruction Device: AeroForm Breast Tissue Expander Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
Study Start Date : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AeroForm Tissue Expansion
AeroForm Breast Tissue Expander placed after mastectomy
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




Primary Outcome Measures :
  1. Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Adverse Events related to the Breast Reconstruction Procedure [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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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): NCT01903174


Locations
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Australia, Western Australia
Mount Hospital
Subiaco, Western Australia, Australia, 6008
Sponsors and Collaborators
AirXpanders, Inc.
Investigators
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Principal Investigator: Tony Connell, F.R.A.C.S. Mount Hospital

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Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT01903174     History of Changes
Other Study ID Numbers: CTP-0004
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

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