Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
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
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
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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Anthony Connell, M.D.
Australia: Department of Health and Ageing Therapeutic Goods Administration