Patient Activated Controlled Expansion (PACE) Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.

Detailed Description
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Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy. Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome. Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial. Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months. Patients will be instructed on the tissue expansion protocol pre-operatively and undergo post-operative clinical follow-up on a weekly basis or more frequently if deemed necessary by the treating surgeon. Each patient will be followed through removal of the tissue expander. Study Population: The study population will consist of up to 10 patients. Eligible patients are females between the ages of 18 and 65 years who are planning to undergo breast reconstruction surgery following mastectomy. Eligible patients must be able to provide informed consent and understand protocol components.

Official Title
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Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

Conditions
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Breast Cancer, Mastectomy, Breast Reconstruction

Intervention / Treatment
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* Device: Patient Activated Controlled Expansion Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female between the ages of 18 and 65 years. Planned breast reconstruction surgery post-mastectomy. Able to provide informed consent. Able to understand protocol components. Exclusion Criteria: Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e., infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration) Residual gross tumor at the intended expansion site History of or planned adjuvant radiation therapy Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications. Obesity with BMI of 30 or above Current smoker Psychologically unsuitable patient Patient unable to understand the protocol for tissue expansion Planned flight or assent to altitude exceeding 1000 meters above baseline during the expansion period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Post-mastectomy<br>Post-mastectomy patients undergoing expander reconstruction | Device: Patient Activated Controlled Expansion Device<br>* Patient activated controlled expansion for post-mastectomy breast reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as evidenced by a low incidence of device-related adverse events. |  | 6 months | 
| Time required to achieve desired expansion results. |  | 6 months | 
| Overall patient treatment satisfaction. |  | 6 months | 
| Overall surgeon treatment satisfaction. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, breast cancer, mastectomy, breast reconstruction, reconstruction, tissue expansion, two-stage breast reconstruction, tissue expander, AeroForm, AirXpander