or
forgot password

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction


Phase 2
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction


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).


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Successful tissue expansion and exchange to a permanent breast implant unless precluded by a non-device related event

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jeffrey A. Ascherman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York-Presbyterian Hospital / Columbia University

Authority:

United States: Food and Drug Administration

Study ID:

CTP-0003 AirXpanders

NCT ID:

NCT01425268

Start Date:

October 2011

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • Tissue Expansion
  • Tissue Expander
  • Breast Tissue Expansion
  • Breast Tissue Expander
  • Breast Reconstruction
  • Two Stage Breast Reconstruction
  • 2 Stage Breast Reconstruction
  • Breast Neoplasms

Name

Location
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Faulkner Hospital Jamaica Plain, Massachusetts  02130
Baptist Medical Center South Jascksonville, Florida  32258
Columbia University New York, New York  10032-3784
Duke University Medical Center Durham, North Carolina  27710
South Nassau Communities Hospital Oceanside, New York  11572
University of California, Irvine Medical Center Orange, California  92868
Marin General Hospital Greenbrae, California  94904
Sutter Healthcare-Sacramento Sacramento, California  95825
Sharp Healthcare - San Diego San Diego, California  91941
Good Samaritan Hospital, San Jose San Jose, California  95008
Mercy Hospital, St. Louis Saint Louis, Missouri  63141
Thornton MD Cosmetic Surgery Center LLC Louisville, Kentucky  40201
Presbyterian Medical Center Charlotte, North Carolina  28207
Center for Breast Restoration, The Methodist Hospital Houston, Texas  77030