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Patient Activated Controlled Expansion (PACE) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.
ClinicalTrials.gov Identifier:
NCT01009008
First received: November 5, 2009
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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 Intervention
Breast Cancer
Mastectomy
Breast Reconstruction
Device: Patient Activated Controlled Expansion Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

Resource links provided by NLM:


Further study details as provided by AirXpanders, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as evidenced by a low incidence of device-related adverse events. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Time required to achieve desired expansion results. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Overall patient treatment satisfaction. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Overall surgeon treatment satisfaction. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post-mastectomy
Post-mastectomy patients undergoing expander reconstruction
Device: Patient Activated Controlled Expansion Device
Patient activated controlled expansion for post-mastectomy breast reconstruction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009008

Locations
Australia, Western Australia
The Mount Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
AirXpanders, Inc.
Investigators
Principal Investigator: Anthony Connell, M.D.
  More Information

No publications provided by AirXpanders, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT01009008     History of Changes
Other Study ID Numbers: CTP-0001
Study First Received: November 5, 2009
Last Updated: June 13, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AirXpanders, Inc.:
cancer
breast cancer
mastectomy
breast reconstruction
reconstruction
tissue expansion
two-stage breast reconstruction
tissue expander
AeroForm
AirXpander

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014