NCT01425268

Patient Controlled Tissue Expansion for Breast Reconstruction

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: AirXpanders, Inc. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.

Detailed description

This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	AeroForm Tissue Expansion	The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
PROCEDURE	Saline Tissue Expansion	A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-08-30
• Last updated: 2017-06-27
• Results posted: 2017-06-27

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study