Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.
ClinicalTrials.gov Identifier:
NCT01425268
First received: August 26, 2011
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.


Condition Intervention Phase
Breast Cancer
Device: AeroForm Tissue Expansion
Procedure: Saline Tissue Expansion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by AirXpanders, Inc.:

Primary Outcome Measures:
  • Successful tissue expansion and exchange to a permanent breast implant unless precluded by a non-device related event [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary endpoint will be assessed when the subject has completed tissue expansion and had an exchange to permanent breast implants. Subjects not completing permanent breast implant procedure will be considered failures if the procedure could not be completed due to a device related event.


Secondary Outcome Measures:
  • The safety of the device will be evaluated by the data collected on device related adverse events, serious device related adverse events, all adverse and serious adverse events (regardless of their relationship to the device), and device malfunctions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    All adverse events will be collected and reported during the time that the expander is implanted. All events will be reported and categorized based on their relationship to the device or procedure. All device malfunctions will be reported.


Estimated Enrollment: 138
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AeroForm Tissue Expansion
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
Device: AeroForm Tissue Expansion
The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
Other Names:
  • AirXpander Tissue Expander System
  • Patient Activated Controlled Expansion (PACE)
  • AeroForm Patient Activated Tissue Expander
  • AeroForm Tissue Expander System
  • AeroForm Tissue Expander
Active Comparator: Saline Tissue Expansion
Saline Tissue Expansion inflated by needle injections of saline
Procedure: Saline Tissue Expansion
A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
Other Names:
  • saline breast tissue expander
  • saline expander
  • breast tissue expander
  • tissue expander

Detailed Description:

This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is a woman between the ages of 18-70.
  2. Subject needs to have tissue expansion as part of her breast reconstruction.
  3. Subject is able to provide written informed consent.
  4. Subject is able and willing to comply with all of the study requirements.
  5. Subject is able to understand and manage at home dosing regimen.

Exclusion Criteria:

  1. Subjects skin is not suitable for tissue expansion.
  2. Subject has remaining tumor cells following her mastectomy.
  3. Subject has a current or prior infection at the intended expansion site.
  4. Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.

4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.

5. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.

6. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).

7. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).

8. Subject is currently participating in a concurrent investigational drug or device study.

9. Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.

12. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.

13. Subject is pregnant or planning on becoming pregnant during the study period.

14. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

  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: NCT01425268

Locations
United States, California
Marin General Hospital
Greenbrae, California, United States, 94904
Susan Downey
Los Angeles, California, United States, 90004
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sutter Healthcare-Sacramento
Sacramento, California, United States, 95825
Good Samaritan Hospital, San Jose
San Jose, California, United States, 95008
United States, Florida
eSSe Plastic Surgery
Fort Lauderdale, Florida, United States, 33308
Baptist Medical Center South
Jacksonville, Florida, United States, 32258
United States, Kentucky
Norton Healthcare Pavilion
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
United States, New York
Columbia University
New York, New York, United States, 10032-3713
South Nassau Communities Hospital
Oceanside, New York, United States, 11572
United States, North Carolina
Presbyterian Medical Center
Charlotte, North Carolina, United States, 28207
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
AirXpanders, Inc.
Investigators
Principal Investigator: Jeffrey A. Ascherman, M.D. New York-Presbyterian Hospital / Columbia University
  More Information

Additional 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: NCT01425268     History of Changes
Other Study ID Numbers: CTP-0003 AirXpanders
Study First Received: August 26, 2011
Last Updated: December 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AirXpanders, Inc.:
Tissue Expansion
Tissue Expander
Breast Tissue Expansion
Breast Tissue Expander
Breast Reconstruction
Two Stage Breast Reconstruction
2 Stage Breast Reconstruction

ClinicalTrials.gov processed this record on April 27, 2015