AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02504424

Run by

AirXpanders, Inc.

People needed

50

Starts

2015-11-12

Expected to finish

2017-09-26

Last updated by the study team

2019-01-29

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Marin General Hospital — Greenbrae, California, United States
• Good Samaritan Hospital, San Jose — San Jose, California, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Faulkner Hospital — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Columbia University — New York, New York, United States
• Presbyterian Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.