Spots Global Cancer Trial Database for Patient Controlled Tissue Expansion for Breast Reconstruction

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Patient Controlled Tissue Expansion for Breast Reconstruction

Official Title: AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction

Study ID: NCT01425268

Conditions

Breast Cancer

Interventions

AeroForm Tissue Expansion

Saline Tissue Expansion

Study Description

Brief 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).