Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
18 Years
65 Years
Female
Breast Cancer, Mastectomy, Breast Reconstruction
Trial Information
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
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.
Inclusion Criteria:
1. Female between the ages of 18 and 65 years.
2. Planned breast reconstruction surgery post-mastectomy.
3. Able to provide informed consent.
4. Able to understand protocol components.
Exclusion Criteria:
1. 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)
2. Residual gross tumor at the intended expansion site
3. History of or planned adjuvant radiation therapy
4. Co-morbid condition determined by the surgeon to pose unduly high risk of surgical
and/or postoperative complications.
5. Obesity with BMI of 30 or above
6. Current smoker
7. Psychologically unsuitable patient
8. Patient unable to understand the protocol for tissue expansion
9. Planned flight or assent to altitude exceeding 1000 meters above baseline during the
expansion period.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Anthony Connell, M.D.
Investigator Role:
Principal Investigator
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
CTP-0001
NCT ID:
NCT01009008
Start Date:
June 2009
Completion Date:
June 2013
Related Keywords:
- Breast Cancer
- Mastectomy
- Breast Reconstruction
- cancer
- breast cancer
- mastectomy
- breast reconstruction
- reconstruction
- tissue expansion
- two-stage breast reconstruction
- tissue expander
- AeroForm
- AirXpander
- Breast Neoplasms
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