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Patient Activated Controlled Expansion (PACE) Trial (PACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01009008
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : August 10, 2018
Information provided by (Responsible Party):
AirXpanders, Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Mastectomy Breast Reconstruction Device: Patient Activated Controlled Expansion Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
Study Start Date : June 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Post-mastectomy
Post-mastectomy patients undergoing expander reconstruction
Device: Patient Activated Controlled Expansion Device
Patient activated controlled expansion for post-mastectomy breast reconstruction

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009008

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Australia, Western Australia
The Mount Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
AirXpanders, Inc.
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Principal Investigator: Anthony Connell, M.D.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AirXpanders, Inc. Identifier: NCT01009008    
Other Study ID Numbers: CTP-0001
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Keywords provided by AirXpanders, Inc.:
breast cancer
breast reconstruction
tissue expansion
two-stage breast reconstruction
tissue expander
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases