Study of AeroForm Tissue Expander for Breast Reconstruction

NCT ID: NCT01903174

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-12-31

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

Conditions

Breast Cancer; Breast Reconstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AeroForm Tissue Expansion

AeroForm Breast Tissue Expander placed after mastectomy

Group Type: EXPERIMENTAL

AeroForm Breast Tissue Expander

Intervention Type: DEVICE

Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide

Interventions

AeroForm Breast Tissue Expander

Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide

Intervention Type: DEVICE

Other Intervention Names

AeroForm; AeroForm Tissue Expander; AirXpander; AirXpander Tissue Expander; AirXpanders Breast Tissue Expander

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AirXpanders, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tony Connell, F.R.A.C.S.

Role: PRINCIPAL_INVESTIGATOR

Mount Hospital

Locations

Mount Hospital

Subiaco, Western Australia, Australia

Countries

Australia

Other Identifiers

CTP-0004

Identifier Type: -

Identifier Source: org_study_id