Trial record 2 of 3 for:
Study of AeroForm Tissue Expander for Breast Reconstruction (ASPIRE)
This study has been completed.
Information provided by (Responsible Party):
First received: July 16, 2013
Last updated: March 21, 2014
Last verified: March 2014
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
Device: AeroForm Breast Tissue Expander
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
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
- AeroForm Tissue Expander
- AeroForm Breast Tissue Expander
- AirXpander Tissue Expander
- AirXpanders Breast Tissue Expander
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
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01903174
|Subiaco, Western Australia, Australia, 6008 |
||Tony Connell, F.R.A.C.S.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 16, 2013
||March 21, 2014
||Australia: Transportation Good Authority (TGA)
Keywords provided by AirXpanders, Inc.:
Breast Tissue Expansion
Breast Tissue Expander
Two Stage Breast Reconstruction
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
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