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This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
Full 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
Enrollment
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Volunteers
Inclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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