Patient Activated Controlled Expansion (PACE) Trial

Breast Cancer Clinical Trial

— PACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009008
• Other study ID #: CTP-0001
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2018
• Source: AirXpanders, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Reconstruction
• Mastectomy

Intervention

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

Locations

Country	Name	City	State
Australia	The Mount Hospital	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
AirXpanders, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety as evidenced by a low incidence of device-related adverse events.		6 months
Secondary	Time required to achieve desired expansion results.		6 months
Secondary	Overall patient treatment satisfaction.		6 months
Secondary	Overall surgeon treatment satisfaction.		6 months