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Patient Controlled Tissue Expansion for Breast Reconstruction (XPAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01425268
Recruitment Status : Completed
First Posted : August 30, 2011
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
AirXpanders, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Device: AeroForm Tissue Expansion Procedure: Saline Tissue Expansion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction
Study Start Date : October 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Expansion Days [ Time Frame: 12 months ]
    The median number of days taken to complete the expansion process.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425268


Locations
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Sponsors and Collaborators
AirXpanders, Inc.
Investigators
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Principal Investigator: Jeffrey A. Ascherman, M.D. New York-Presbyterian Hospital / Columbia University
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AirXpanders, Inc.
ClinicalTrials.gov Identifier: NCT01425268    
Other Study ID Numbers: CTP-0003 AirXpanders
First Posted: August 30, 2011    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
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