AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Study Overview
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Brief Summary
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This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.

Detailed Description
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This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).

Official Title
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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: AeroForm 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 requires tissue expansion as part of breast reconstruction 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's tissue integrity is unsuitable for tissue expansion Subject has residual gross malignancy at the intended expansion site Subject has current or prior infection at the intended expansion site Subject has a history of failed tissue expansion or breast reconstruction 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 taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).

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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Accepts Healthy Volunteers

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 Expander<br>AeroForm Tissue Expansion inflation with carbon dioxide by remote control | Device: AeroForm Tissue Expander<br>* The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event | The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort. | Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in the analyses due to not completing the second stage surgery and withdrawal of consent. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tissue Expansion, Tissue Expander, Breast Tissue Expansion, Breast Tissue Expander, Breast Reconstruction, 2 Stage Breast Reconstruction