Patient Controlled Tissue Expansion for Breast Reconstruction

Study Overview
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Brief Summary
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This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.

Detailed Description
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This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).

Official Title
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AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: AeroForm Tissue Expansion
* Procedure: Saline Tissue Expansion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a woman between the ages of 18-70. Subject needs to have tissue expansion as part of her breast reconstruction. Subject is able to provide written informed consent. Subject is able and willing to comply with all of the study requirements. Subject is able to understand and manage at home dosing regimen. Exclusion Criteria: Subjects skin is not suitable for tissue expansion. Subject has remaining tumor cells following her mastectomy. Subject has a current or prior infection at the intended expansion site. Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used. 4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted. 5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site. 6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes). 7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin). 8. Subject is currently participating in a concurrent investigational drug or device study. 9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted. 12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device. 13. Subject is pregnant or planning on becoming pregnant during the study period. 14. 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AeroForm Tissue Expansion<br>AeroForm Tissue Expansion inflation with carbon dioxide by remote control | Device: AeroForm Tissue Expansion<br>* The AeroForm Patient Controlled 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>* Other names: AeroForm Tissue Expander;|
| Active Comparator: Saline Tissue Expansion<br>Saline Tissue Expansion inflated by needle injections of saline | Procedure: Saline Tissue Expansion<br>* A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.<br>* Other names: 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 a Permanent Breast Implant Unless Precluded by a Non-device Related Event | The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expansion Days | The median number of days taken to complete the expansion process. | 12 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, Two Stage Breast Reconstruction, 2 Stage Breast Reconstruction