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AirXpanders AeroForm Tissue Expander System for Breast Reconstruction — XPAND-II  

Breast Cancer Clinical Trial

Official title:
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)

Clinical Trial Summary

This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.

Clinical Trial Description

This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02504424
Study type Interventional
Source AirXpanders, Inc.
Contact
Status Completed
Phase N/A
Start date November 12, 2015
Completion date September 26, 2017
View Details
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