Study of AeroForm Tissue Expander for Breast Reconstruction (ASPIRE)

AirXpanders

Status: Completed

Conditions: Breast Reconstruction; Breast Cancer

Treatments: Device: AeroForm Breast Tissue Expander

Study type: Interventional

Funder types: Industry

Identifiers

NCT01903174

CTP-0004

Details and patient eligibility

About

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

Full 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

Enrollment: 21 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

AeroForm Tissue Expansion

Experimental group

Description:

AeroForm Breast Tissue Expander placed after mastectomy

Treatment:

Device: AeroForm Breast Tissue Expander