Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: AeroForm Tissue Expansion; Procedure: Saline Tissue Expansion

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).

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Greenbrae, California, United States, 94904
      • Marin General Hospital
    • Los Angeles, California, United States, 90004
      • Susan Downey
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
    • Sacramento, California, United States, 95825
      • Sutter Healthcare-Sacramento
    • San Jose, California, United States, 95008
      • Good Samaritan Hospital, San Jose
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • eSSe Plastic Surgery
    • Jacksonville, Florida, United States, 32258
      • Baptist Medical Center South
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare Pavilion
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02130
      • Faulkner Hospital
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Memorial Medical Center
  • New York
    • New York, New York, United States, 10032-3713
      • Columbia University
    • Oceanside, New York, United States, 11572
      • South Nassau Communities Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Novant Health Presbyterian Medical Center
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: AeroForm Tissue Expander; AirXpander Tissue Expander System; Patient Activated Controlled Expansion (PACE); AeroForm Patient Activated Tissue Expander; AeroForm Tissue Expander System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event	The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expansion Days	The median number of days taken to complete the expansion process.	12 months

Collaborators and Investigators

• Sponsor: AirXpanders, Inc.
• Investigators: Principal Investigator: Jeffrey A. Ascherman, M.D., New York-Presbyterian Hospital / Columbia University

Publications and helpful links

General Publications

• Ascherman JA, Zeidler K, Morrison KA, Appel JZ, Berkowitz RL, Castle J, Colwell A, Chun Y, Johnson D, Mohebali K. Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial. Plast Reconstr Surg. 2016 Dec;138(6):1161-1170. doi: 10.1097/PRS.0000000000002784.
• Zeidler KR, Berkowitz RL, Chun YS, Alizadeh K, Castle J, Colwell AS, Desai AR, Evans G, Hollenbeck S, Johnson DJ, Morris D, Ascherman JA. AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial. Ann Plast Surg. 2014 May;72 Suppl 1:S51-5. doi: 10.1097/SAP.0000000000000175.

Helpful Links

• AirXpanders

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (ESTIMATE): August 30, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Breast Reconstruction; Tissue Expander; Tissue Expansion; Breast Tissue Expansion; Breast Tissue Expander; 2 Stage Breast Reconstruction; Two Stage Breast Reconstruction
• Other Study ID Numbers: CTP-0003 AirXpanders

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes