- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903174
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
-
-
Western Australia
-
Subiaco, Western Australia, Australia, 6008
- Mount Hospital
-
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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:
- Subject is female between the ages of 18 - 70.
- Subject has elected two stage breast reconstruction with tissue expanders.
- Subject's tissue is amenable to tissue expansion.
- 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 has residual gross malignancy following mastectomy.
- Subject has a current infection at the intended expansion site.
- Subject has clinically significant radiation fibrosis at the expansion site.
- Subject has planned radiation at the intended expansion site during the time the expander is implanted.
- 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 currently participating in a concurrent investigational drug or device study.
- Subject is a current tobacco smoker.
- Subject is overweight with a BMI > 33.
- Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- Subject is pregnant or planning to become pregnant during the study period.
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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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
|
Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
Other Names:
|
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
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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