Study of AeroForm Tissue Expander for Breast Reconstruction (ASPIRE)

March 21, 2014 updated by: AirXpanders, Inc.

AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Mount Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events related to the Breast Reconstruction Procedure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AirXpanders, Inc.

Investigators

  • Principal Investigator: Tony Connell, F.R.A.C.S., Mount Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (ESTIMATE)

July 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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