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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Patient Activated Controlled Expansion (PACE) Trial
Scientific title
Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Mastectomy 0 0
Breast Reconstruction 0 0
Condition category
Condition code
Cancer 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Devices - Patient Activated Controlled Expansion Device

Experimental: Post-mastectomy - Post-mastectomy patients undergoing expander reconstruction

Treatment: Devices: Patient Activated Controlled Expansion Device
Patient activated controlled expansion for post-mastectomy breast reconstruction

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Safety as evidenced by a low incidence of device-related adverse events.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Time required to achieve desired expansion results.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Overall patient treatment satisfaction.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Overall surgeon treatment satisfaction.
Timepoint [4] 0 0
6 months

Key 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.
Minimum age
18 Years
Maximum age
65 Years
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Mount Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
AirXpanders, Inc.

Ethics approval
Ethics application status

Brief summary
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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Anthony Connell, M.D.
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications