Patient Activated Controlled Expansion (PACE) Trial (PACE)
Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Western Australia
-
Perth, Western Australia, Australia, 6000
- The Mount Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post-mastectomy
Post-mastectomy patients undergoing expander reconstruction
|
Patient activated controlled expansion for post-mastectomy breast reconstruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety as evidenced by a low incidence of device-related adverse events.
Time Frame: 6 months
|
6 months
|
|
Time required to achieve desired expansion results.
Time Frame: 6 months
|
6 months
|
|
Overall patient treatment satisfaction.
Time Frame: 6 months
|
6 months
|
|
Overall surgeon treatment satisfaction.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony Connell, M.D.
Publications and helpful links
General Publications
- Connell TF. Patient-activated controlled expansion for breast reconstruction using controlled carbon dioxide inflation: confirmation of a feasibility study. Plast Reconstr Surg. 2014 Oct;134(4):503e-511e. doi: 10.1097/PRS.0000000000000551.
- Connell AF. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg. 2011 Oct;128(4):848-852. doi: 10.1097/PRS.0b013e3182268b80.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP-0001
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