Patient Controlled Tissue Expansion for Breast Reconstruction

Breast Cancer Clinical Trial

— XPAND  

Official title:

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425268
• Other study ID #: CTP-0003 AirXpanders
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2011
• Last updated: November 5, 2015
• Start date: October 2011
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: AirXpanders, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Presbyterian Medical Center	Charlotte	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	eSSe Plastic Surgery	Fort Lauderdale	Florida
United States	Marin General Hospital	Greenbrae	California
United States	The Methodist Hospital	Houston	Texas
United States	Baptist Medical Center South	Jacksonville	Florida
United States	Susan Downey	Los Angeles	California
United States	Norton Healthcare Pavilion	Louisville	Kentucky
United States	Columbia University	New York	New York
United States	South Nassau Communities Hospital	Oceanside	New York
United States	University of California, Irvine Medical Center	Orange	California
United States	Sutter Healthcare-Sacramento	Sacramento	California
United States	Good Samaritan Hospital, San Jose	San Jose	California
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AirXpanders, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful tissue expansion and exchange to a permanent breast implant unless precluded by a non-device related event	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.	6 months	No
Secondary	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	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.	6 months	Yes

External Links

•   AirXpanders