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

November 5, 2009
June 13, 2013
June 2009
May 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01009008 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Patient Activated Controlled Expansion (PACE) Trial
Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Mastectomy
  • Breast Reconstruction
Device: Patient Activated Controlled Expansion Device
Patient activated controlled expansion for post-mastectomy breast reconstruction
Experimental: Post-mastectomy
Post-mastectomy patients undergoing expander reconstruction
Intervention: Device: Patient Activated Controlled Expansion Device
Connell AF. Patient-activated controlled expansion for breast reconstruction with controlled carbon dioxide inflation: a feasibility study. Plast Reconstr Surg. 2011 Oct;128(4):848-52. doi: 10.1097/PRS.0b013e3182268b80.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2013
May 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01009008
CTP-0001
Yes
AirXpanders, Inc.
AirXpanders, Inc.
Not Provided
Principal Investigator: Anthony Connell, M.D.
AirXpanders, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP