NCT02504424

AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: AirXpanders, Inc. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	AeroForm Tissue Expander	The AeroForm 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.

Timeline

• Start date: 2015-11-12
• Primary completion: 2017-05-03
• Completion: 2017-09-26
• First posted: 2015-07-22
• Last updated: 2019-01-29
• Results posted: 2018-09-05

Locations

8 sites across 1 country: United States