Study of AeroForm Tissue Expander for Breast Reconstruction

Breast Cancer Clinical Trial

— ASPIRE  

Official title:

AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903174
• Other study ID #: CTP-0004
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: March 21, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: AirXpanders, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Transportation Good Authority (TGA)
• Study type: Interventional

Clinical Trial Summary

This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction

Description:

The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subject is female between the ages of 18 - 70.

2. Subject has elected two stage breast reconstruction with tissue expanders.

3. Subject's tissue is amenable to tissue expansion.

4. Subject is able to provide written informed consent.

5. Subject is able and willing to comply with all of the study requirements.

6. Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen.

Exclusion Criteria:

1. Subject has residual gross malignancy following mastectomy.

2. Subject has a current infection at the intended expansion site.

3. Subject has clinically significant radiation fibrosis at the expansion site.

4. Subject has planned radiation at the intended expansion site during the time the expander is implanted.

5. Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).

6. Subject is currently participating in a concurrent investigational drug or device study.

7. Subject is a current tobacco smoker.

8. Subject is overweight with a BMI > 33.

9. Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.

10. Subject is pregnant or planning to become pregnant during the study period.

11. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Reconstruction

Intervention

Device:
• AeroForm Breast Tissue Expander
Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide

Locations

Country	Name	City	State
Australia	Mount Hospital	Subiaco	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
AirXpanders, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event		6 months	No
Secondary	Adverse Events related to the Breast Reconstruction Procedure		6 months	Yes

External Links

•   AirXpanders Inc.