N/A
Completed N=50
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
Source: ClinicalTrials.gov NCT02504424 ↗Enrolled (actual)
50
Serious AEs
22.0%
Results posted
Sep 2018
Primary outcomePrimary: Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event — 80 breasts
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event |
80 | — |
| SECONDARY Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort. |
80 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02504424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.