N/A
N=158
Patient Controlled Tissue Expansion for Breast Reconstruction
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01425268 ↗Enrolled (actual)
158
Serious AEs
18.5%
Results posted
Jun 2017
Primary outcome: Primary: Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event — 149; 82 Breasts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AeroForm Tissue Expansion (Device); Saline Tissue Expansion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AirXpanders, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event |
149; 82 | — |
| SECONDARY Expansion Days |
21; 46 | <0.0001 sig |
Summary
This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.
Eligibility Criteria
Inclusion Criteria
- Subject is a woman between the ages of 18-70.
- Subject needs to have tissue expansion as part of her breast reconstruction.
- Subject is able to provide written informed consent.
- Subject is able and willing to comply with all of the study requirements.
- Subject is able to understand and manage at home dosing regimen.
Exclusion Criteria
- Subjects skin is not suitable for tissue expansion.
- Subject has remaining tumor cells following her mastectomy.
- Subject has a current or prior infection at the intended expansion site.
- Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.
4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.
- Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.
- Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).
- Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).
- Subject is currently participating in a concurrent investigational drug or device study.
- Subject is a current tobacco smoker. 10. Subject is overweight (BMI > 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.
- Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- Subject is pregnant or planning on becoming pregnant during the study period.
- Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
Data sourced from ClinicalTrials.gov (NCT01425268). 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.