AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Not Applicable

Completed

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

Subject is female between the ages of 18-70
Subject requires tissue expansion as part of breast reconstruction
Subject is able to provide written informed consent
Subject is able and willing to comply with all of the study requirements
Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen

Exclusion Criteria

Subject's tissue integrity is unsuitable for tissue expansion
Subject has residual gross malignancy at the intended expansion site
Subject has current or prior infection at the intended expansion site
Subject has a history of failed tissue expansion or breast reconstruction
Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)
Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).

Arm && Interventions

Group	Intervention	Description
AeroForm Tissue Expander	AeroForm Tissue Expander	AeroForm Tissue Expansion inflation with carbon dioxide by remote control

Primary Outcome Measures

Name	Time	Method
Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event	6 months	The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.

Secondary Outcome Measures

Name	Time	Method
Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.	6 months	Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in the analyses due to not completing the second stage surgery and withdrawal of consent.

Locations (8): Marin General Hospital
🇺🇸
Greenbrae, California, United States
University of Massachusetts Memorial Medical Center
🇺🇸
Worcester, Massachusetts, United States
Faulkner Hospital
🇺🇸
Boston, Massachusetts, United States
Broward Health Medical Center
🇺🇸
Fort Lauderdale, Florida, United States
Presbyterian Medical Center
🇺🇸
Charlotte, North Carolina, United States
Good Samaritan Hospital, San Jose
🇺🇸
San Jose, California, United States
Columbia University
🇺🇸
New York, New York, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States