Trial record 2 of 3 for:    airxpanders

Study of AeroForm Tissue Expander for Breast Reconstruction (ASPIRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.
ClinicalTrials.gov Identifier:
NCT01903174
First received: July 16, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Breast Cancer
Breast Reconstruction
Device: AeroForm Breast Tissue Expander

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by AirXpanders, Inc.:

Primary Outcome Measures:
  • Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events related to the Breast Reconstruction Procedure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • AeroForm Breast Tissue Expander
  • AirXpander
  • AirXpander Tissue Expander
  • AirXpanders Breast Tissue Expander

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01903174

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

Additional Information:
No publications provided

Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT01903174     History of Changes
Other Study ID Numbers: CTP-0004
Study First Received: July 16, 2013
Last Updated: March 21, 2014
Health Authority: Australia: Transportation Good Authority (TGA)

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 23, 2014