NCT01903174

Study of AeroForm Tissue Expander for Breast Reconstruction

AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: AirXpanders, Inc. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	AeroForm Breast Tissue Expander	Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2013-07-19
• Last updated: 2014-03-26

Locations

1 site across 1 country: Australia