Study of AeroForm Tissue Expander for Breast Reconstruction

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

Detailed Description
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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

Official Title
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AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction

Conditions
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Breast Cancer, Breast Reconstruction

Intervention / Treatment
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* Device: AeroForm Breast Tissue Expander


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AeroForm Tissue Expansion<br>AeroForm Breast Tissue Expander placed after mastectomy | Device: AeroForm Breast Tissue Expander<br>* Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide<br>* Other names: AirXpanders Breast Tissue Expander;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events related to the Breast Reconstruction Procedure |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Breast Reconstruction, Breast Tissue Expansion, Breast Tissue Expander, Two Stage Breast Reconstruction