Study of AeroForm Tissue Expander for Breast Reconstruction

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Reconstruction
• Interventions: Device: AeroForm Breast Tissue Expander

• Registration Number: NCT01903174
• Lead Sponsor: AirXpanders, Inc.

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AeroForm Tissue Expansion	AeroForm Breast Tissue Expander	AeroForm Breast Tissue Expander placed after mastectomy

Primary Outcome Measures

Name	Time	Method
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event	6 months

Secondary Outcome Measures

Name	Time	Method
Adverse Events related to the Breast Reconstruction Procedure	6 months

Trial Locations

Locations (1)

Mount Hospital; 🇦🇺 Subiaco, Western Australia, Australia