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Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)

This study is currently recruiting participants.
Verified April 2014 by AirXpanders, Inc.
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.
ClinicalTrials.gov Identifier:
NCT01425268
First received: August 26, 2011
Last updated: April 2, 2014
Last verified: April 2014

August 26, 2011
April 2, 2014
October 2011
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01425268 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Patient Controlled Tissue Expansion for Breast Reconstruction
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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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
  • Experimental: AeroForm Tissue Expansion
    AeroForm Tissue Expansion inflation with carbon dioxide by remote control
    Intervention: Device: AeroForm Tissue Expansion
  • Active Comparator: Saline Tissue Expansion
    Saline Tissue Expansion inflated by needle injections of saline
    Intervention: Procedure: Saline Tissue Expansion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
138
January 2015
December 2014   (final data collection date for primary outcome measure)

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.

Female
18 Years to 70 Years
Yes
Contact: Kathryn L Kelley, R.N., B.S.N. 650-390-9003 kkelley@airxpanders.com
Contact: Scott Dodson, B.S. 650-390-9000 sdodson@airxpanders.com
United States
 
NCT01425268
CTP-0003 AirXpanders
Yes
AirXpanders, Inc.
AirXpanders, Inc.
Not Provided
Principal Investigator: Jeffrey A. Ascherman, M.D. New York-Presbyterian Hospital / Columbia University
AirXpanders, Inc.
April 2014

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